Design and management services for the activation I-131 API manufacturing facility at necsa pelindaba

Bidders must complete the Requirements Traceability Matrix (RTM) template on a line-by-line basis, indicating compliance for each requirement as "YES", "NO", or "N/A". The "Information" column must be marked "YES" for information-only requirements with reasons in the comments column, otherwise "N/A". The "Comply" column requires "YES" for full compliance with a referenced compliance document number in comments, "NO" for non-compliance or partial compliance with reasons, or "N/A" for information-only items. The "Partial Comply" column requires "YES" for partial compliance with reasons, otherwise "N/A". Failure to complete the RTM correctly will lead to disqualification.

No eligibility criteria specified

The tender is for the appointment of a professional engineering services (design and management) firm to modify an existing structure for the establishment of a Radioiodine Active Pharmaceutical Ingredient (API) facility. The RTM template references User Requirement Specification (URS) references and sub-references with requirement descriptions, indicating bidders must demonstrate compliance against detailed technical requirements.

No specific requirements found

The bid is for the appointment of professional engineering services (design and management) firm for the modification of an existing structure for the establishment of a Radioiodine Active Pharmaceutical Ingredient (API) facility.

Necsa Confidentiality Agreement must be completed, signed and submitted with the bid. The agreement binds the bidder to protect Necsa's confidential information, trade secrets and intellectual property disclosed during the tender process and any subsequent contract. Unauthorised disclosure or use of such information is prohibited and may result in legal action and disqualification.

Closing date: 16 September 2026 at 11:00.

Non-compulsory site meeting: 26 August 2026 at 10:00 (physical at Necsa Pelindaba and virtual via Microsoft Teams).

Deadline to send ID copies for site access: 25 August 2026 at 16:00 to [email protected].

Bid validity period: 90 days from closing date.

Clarity seeking questions must be submitted at least 3 working days before closing.

SCM enquiries: Mr Buyani Nsibande, [email protected], +27 (0)12 305 6072.

Site meeting access: [email protected].

Submission: Online via eTenders link provided.

Submit via eTenders online at https://www.etenders.gov.za/Esubmission/esubmission?id=FIN-SCM-TEN-0246.

Also submit two hard copies (one original and one copy) and one electronic copy (on disk or memory stick) in a sealed envelope. Envelope size must not exceed 400mm x 100mm x 150mm.

Only international suppliers may submit bids via email.

Technical Proposal and Pricing Proposal must be in separate sealed envelopes (Envelope One and Envelope Two). No pricing in Envelope One.

All pages must be initialled by the authorised signatory. Handwritten pricing not accepted.

Returnable forms (all must be completed and signed):

• Necsa Safety, Health and Environmental Requirements for Contractors (pro forma)
• Necsa Alcohol and Drug Control Policy
• Necsa Confidentiality Agreement
• Necsa Terms and Conditions of Contract
• SBD 1 (Invitation to Bid)
• SBD 3.1 (Pricing Schedule – Firm Prices)
• SBD 4 (Declaration of Interest)
• SBD 6.1 (Preference Points Claim)
• SBD 7.1 (Contract Form – Purchase of Goods/Works)
• POPIA Data Processing Agreement (FIN-SCM-AGR-0002)
• Consortium/joint venture agreement (if applicable)
• SARS tax pin
• Valid tax clearance certificate and BBBEE certificate (or sworn affidavit)
• COIDA certificate or proof of application
• Proof of Professional Indemnity cover of at least R5 million
• Completed Bidder Information (Section 7)
• Traceable proof of at least 2 successfully completed cGMP projects
• Completed Requirements Traceability Matrix (RTM) demonstrating compliance with NTP-SPE-4162 Rev 2 and NTP-SPE-4168 Rev 1
• Cover letter with statement confirming full scope delivery per NTP-SOW-4019
• Proof of ISO 9001:2015 accreditation or equivalent in-house quality system
• Overall project cost estimate
• Statement of participation in RFI process (FIN-SCM-RFI-0003)
• Company profile indicating years in business
• CVs of key personnel with professional registration and cGMP experience
• Detailed project schedule (Level 5 WBS recommended)

Evaluation is in three stages:

1. Hurdle requirements (automatic disqualification if any not met):

• Valid COIDA certificate or proof of application
• Completed and signed POPIA document (FIN-SCM-AGR-0002)
• Proof of Professional Indemnity cover of at least R5 million in bidding company's name
• Fully completed Bidder Information (Section 7)
• Traceable proof of at least 2 successfully completed cGMP facilities (with contact details)
• Completed RTM demonstrating compliance (or partial compliance with justification) with NTP-SPE-4162 Rev 2 and NTP-SPE-4168 Rev 1
• Cover letter statement confirming full scope delivery per NTP-SOW-4019
• Proof of ISO 9001:2015 accreditation or equivalent in-house quality system
• Overall project cost estimate
• Statement of participation in RFI process (FIN-SCM-RFI-0003)

2. Technical/Functional evaluation (100 points, minimum 80 to proceed):

• Company experience in design of cGMP facilities (20 pts): >10 years=20, 5-10=10, 1-5=5, 0=0
• Similar service to radiopharmaceutical industry (20 pts): 3+ projects=20, <3=10, none=0
• Similar service to pharmaceutical/medical industry (20 pts): 5+ projects=20, 3-4=10, <3=0
• Company organisational structure with key personnel CVs (20 pts): detailed structure with design, quality, GMP roles, professional registration, and min 5 years relevant experience=20; structure without those details=10; none=0
• Detailed project schedule (20 pts): Level 5 WBS=20; less detailed=10; none=0

3. Price and preference points:

• 80/20 or 90/10 system applies depending on total value.
• Price points calculated using PPPFA formula.
• Specific goal (ownership): points for black ownership levels (100% black ownership=20 or 10 points depending on system; 51-99%=15/7.5; 40-50%=10/5; 1-39%=5/2.5; 0%=0).
• Contract awarded to highest total points, subject to market-related price check.

Scope: Professional engineering design and project management services (Stages 1–6 per ECSA framework) for modification of an existing structure (Building P1900 at Necsa Pelindaba, North-West Province) to establish a Radioiodine Active Pharmaceutical Ingredient (API) facility.

The facility must comply with current Good Manufacturing Practice (cGMP) as prescribed by SAHPRA, PIC/S, ISO 14644, and other national/international standards.

Key deliverables:

• Fully compliant detailed facility design and specification documents for construction.
• Construction cost estimations.
• Project management and oversight through procurement, construction, commissioning, and qualification.
• Validation lifecycle: Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ).

The project is divided into six sequential stages with Gate reviews at each stage. Progression is not guaranteed; NTP may terminate at any Gate without penalty.

Excluded: hot cell production line and associated in-cell equipment.

The service provider must comply with referenced documents: NTP-SPE-4162 Rev 2, NTP-SPE-4168 Rev 1, NTP-SOW-4019 Rev 2.

Must submit a Requirements Traceability Matrix (RTM) demonstrating compliance.

Cost estimation must indicate error percentages and costing model.

All required supporting documents will be shared after signing a non-disclosure agreement (NDA).

Fixed price tender. Bidders must include all costs for successful completion.

Pricing schedule covers six stages plus facility validation and a contingency amount of R250,000 (to be expended only with written client approval).

15% VAT to be added.

Overall project cost estimate required as part of submission.

Professional Indemnity cover of at least R5 million in the bidding company's name is mandatory.

No bond or guarantee explicitly mentioned.

Mandatory compliance documents (non-submission leads to disqualification):

• Valid COIDA certificate or proof of application.
• Completed and signed POPIA Data Processing Agreement (FIN-SCM-AGR-0002).
• Proof of Professional Indemnity cover of at least R5 million.
• SARS tax pin and valid tax clearance certificate.
• Valid BBBEE certificate or sworn affidavit (for ownership points).
• Proof of ISO 9001:2015 accreditation or equivalent in-house quality system.
• Statement of participation in RFI process (FIN-SCM-RFI-0003).
• Completed Bidder Information form.
• Proof of at least 2 successfully completed cGMP facilities.
• Completed RTM.
• Cover letter confirming full scope delivery.
• Overall project cost estimate.
• Consortium/joint venture agreement if applicable.
• Necsa-specific forms: SHE requirements, Alcohol and Drug Policy, Confidentiality Agreement, Terms and Conditions.
• Standard SBD forms: 1, 3.1, 4, 6.1, 7.1.
• Successful bidder must register as a Necsa supplier.

User Requirements Specification (URS) for the Building Management System (BMS) to be installed in the Activation Iodine-131 API Manufacturing Facility, located in Building P1900 on the Necsa site (R104, Pelindaba, Brits Magisterial District). The document defines functional, technical, and performance expectations to ensure the system meets operational needs and regulatory compliance for GMP manufacturing of Iodine-131 Active Pharmaceutical Ingredient. NTP Radioisotopes SOC Ltd (subsidiary of NECSA) is the facility owner. The URS covers design, manufacture, installation, commissioning, qualification, and documentation of the BMS.

Bidders must be registered on the National Treasury Central Supplier Database (CSD) and hold a valid SARS Tax Clearance Certificate (TCS) or tax pin. B-BBEE status level must be claimed on SBD 6.1. The service provider must comply with SAHPRA GMP, GAMP 5, PIC/S PE 009 Annex 11, FDA 21 CFR Part 11, WHO TRS 1033, and NTP quality procedures. Professional engineering registration (e.g. ECSA) is implied by the scope. All documentation must conform to ALCOA+ principles. The bidder must complete and sign SBD 1 (Invitation to Bid), SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim), SBD 8 (Declaration of Bidder's Past SCM Practices), SBD 9 (Certificate of Independent Bid Determination), and an Authority to Sign / Board Resolution.

Scope: Design, manufacture, installation, commissioning, qualification and documentation of a Building Management System (BMS) for the Activation Iodine-131 API Manufacturing Facility in Building P1900 on the Necsa site (R104, Pelindaba, Brits Magisterial District).

System purpose: Continuous monitoring, logging and alarming of equipment, services and systems parameters including room differential and absolute pressures, temperatures, and relative humidity to support GMP operation.

Architecture: Hierarchical — field devices, distributed automation controllers (DDC/PLC), and supervisory system (SCADA). Controllers must operate autonomously; loss of supervisory communication must not interrupt critical control functions (e.g. HVAC).

Communication: Primary protocol BACnet/IP; support for Modbus, LonWorks, Ethernet as required for equipment integration. All components must maintain synchronised time via facility IT NTP service; alarm on loss of sync.

Integration: HVAC (including chilled water), differential pressure monitoring, compressed air, nitrogen gas, UPS and generator, Low Activity (LA) effluent, chemical/industrial effluent systems.

Functional areas: HVAC control (temperature, pressure, humidity, airflow, ACPH), pressure cascade control between classified areas, ventilation and air quality, energy management, alarm management, scheduling/automation, equipment sequencing and interlocking, operating modes (including emergency exhaust), fault handling and failover, manual override with role-based security and audit logging.

Performance: Temperature control accuracy ±0.5°C; humidity control accuracy ±2% RH; differential pressure and airflow accuracy per facility design documentation; ACPH monitoring for classified areas; stable reliable control under normal operating conditions.

Data management: Secure storage and retrieval of historical data, alarms, events, trends; configurable logging intervals and retention aligned with NTP and GMP requirements; export capability for engineering, maintenance, compliance.

Alarm management: Real-time alarms for environmental deviations, equipment faults, communication failures, critical events; configurable priorities, acknowledgement, handling per facility alarm philosophy; historical alarm records retained.

Cybersecurity: Role-based access control (RBAC) aligned with operational responsibilities; audit trails for critical actions, configuration changes, overrides; secure communication (HTTPS/TLS); compliance with NIST Cybersecurity Framework; periodic vulnerability assessments.

Documentation: User operation manuals, installation/configuration guides, maintenance/troubleshooting procedures, as-built documentation (wiring schematics, network topology, equipment layouts, equipment lists, I/O lists), system configuration documentation (parameter settings, network config, backup/recovery procedures, user access config, backup files, controller configs, graphics configs, parameter databases, administrative credentials). Proprietary engineering software subject to vendor licensing.

Validation: Supplier must support DQ, IQ, OQ, PQ per NTP-SOP-7077 and GAMP 5; provide protocols, test documentation, commissioning records, traceability; all supplier documentation must conform to ALCOA+ principles.

Training: Comprehensive training including user manuals, quick-reference guides, on-site sessions for operators/administrators, maintenance training (troubleshooting, preventive maintenance, fault diagnosis).

Maintenance and support: Vendor to provide technical support during defects liability/warranty period including fault diagnosis, corrective support, software support.

Change management: All changes managed per NTP-PRG-0732; documented, reviewed, approved, communicated; change log maintained.

Compliance standards: ASHRAE 135 / ISO 16484-5 (BACnet), IEC 62443 (cybersecurity), ISO 41001, SANS 10400, SANS 204, ISO 50001:2018, OHS Act, SANS 10142-1, ISPE GAMP 5, PIC/S PE 009 Annex 11, FDA 21 CFR Part 11, PIC/S PI 041-1, WHO TRS 1033 Annex 4, WHO TRS 1019 Annex 3, SAHPRA GMP Guideline (SAHPGL-INSP-02_v10).

Control philosophy: Automatic control of environmental and mechanical systems to maintain defined operational conditions; configurable control strategies to regulate equipment, maintain parameters within limits, ensure safe, stable, efficient operation under all defined conditions.

Controller autonomy: Automation controllers capable of independent operation; continue control functions without supervisory system; loss of communication must not result in loss of control, unsafe operation, or interruption of critical environmental control (e.g. HVAC).

Scheduling and automation: HVAC cycles and system operations scheduled based on time-of-day or occupancy levels; automation rules configurable to reduce manual intervention.

Equipment sequencing and interlocking: Automatic sequencing and interlocking to ensure proper operational order, prevent equipment damage, maintain efficiency; equipment operates only when operational conditions and permissive interlocks satisfied; specific sequences defined in Functional Design Specification (FDS).

Operating modes and state management: Support monitoring and control of HVAC operating modes including emergency exhaust; emergency sequences, permissives, interlocks defined in FDS and implemented per approved control philosophy; transitions based on operational conditions, schedules, operator commands, safety requirements.

Fault handling and failover: Detection of equipment faults, communication failures, abnormal conditions; generation of appropriate alarms; execution of predefined control actions to maintain safe operation and minimise disruption.

Manual override: Authorised personnel may manually override automatic control for operational, maintenance, emergency purposes; overrides must not compromise safety, equipment protection, critical environmental control; secured access, role-based, logged, notified.

Automatic resumption: Defined criteria, timing, manual confirmation for resuming automatic control after override; conditional on resolution of override conditions and restoration of normal operation.

Safety and emergency response: Predefined safety control actions for emergency conditions including external safety system signals; protection of personnel, equipment, facility.

Commissioning methodology: Phased commissioning to maintain facility operations; pre-commissioning checklists; detailed schedules; coordination with other teams; validation aligned with project lifecycle (FAT, SAT, IQ, OQ, PQ).

Change management: All changes per NTP-PRG-0732; documented, reviewed, approved, communicated; change log maintained.

Audit trail requirements: Secure, computer-generated audit trails for critical operator actions, configuration changes, alarm acknowledgements, overrides, system modifications; records include user identification, timestamps, affected parameters, previous and updated values; audit trails not modifiable by standard users.

Data integrity: Electronic records comply with ALCOA+ principles and GMP data integrity requirements; support compliant electronic signatures; protection against unauthorised modification, deletion, corruption; secure retention for approved periods.

Validation: BMS designed and documented to support GMP validation per GAMP 5 and regulatory requirements; supplier documentation provides sufficient detail and traceability for NTP validation activities (IQ, OQ, PQ).

Documentation: Comprehensive documentation including user manuals, installation/configuration guides, maintenance procedures, as-built documentation, system configuration documentation; updated for brownfield, progressive for greenfield.

Supplier quality: Supplier qualification and compliance assessment; pre-shipment testing; defect notification; ALCOA+ compliance for all supplier-generated documentation.

Change control: Managed per NTP-PRG-0732; documented, reviewed, approved, communicated; change log maintained.

Commissioning and validation plan: Validation activities aligned with project lifecycle; validation documentation with protocols, summary reports, traceability to URS; phased commissioning; coordination with teams.

Regulatory compliance: SAHPRA GMP (SAHPGL-INSP-02_v10), GAMP 5, PIC/S PE 009 Annex 11, FDA 21 CFR Part 11, WHO TRS 1033 Annex 4, WHO TRS 1019 Annex 3, NTP quality procedures (NTP-SOP-7006, NTP-PRG-0300, NTP-PRG-0400, NTP-PRG-0732, NTP-SOP-7077).

Data integrity: All electronic records and documentation must conform to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Local regulations: SANS 10142-1 (electrical installation), OHS Act, SANS 10400 (building regulations), SANS 204 (energy efficiency), ISO 50001:2018 (energy management).

Industry standards: ASHRAE 135 / ISO 16484-5 (BACnet), IEC 62443 (industrial cybersecurity), ISO 41001 (facility management).

Cybersecurity: NIST Cybersecurity Framework guidelines; secure protocols (HTTPS, TLS); periodic vulnerability assessments.

Professional registration: Professional engineering registration (e.g. ECSA) implied by scope of professional engineering services for design and management.

Standard returnable forms (per tender record): SBD 1 (Invitation to Bid), SBD 4 (Declaration of Interest), SBD 6.1 (Preference Points Claim), SBD 8 (Declaration of Bidder's Past SCM Practices), SBD 9 (Certificate of Independent Bid Determination), Authority to Sign / Board Resolution.

Mandatory registrations: CSD registration, valid SARS Tax Clearance Certificate or tax pin, B-BBEE status level claimed on SBD 6.1.

Environmental monitoring for safety: BMS shall monitor and alarm environmental parameters supporting facility safety and regulatory compliance, including HVAC parameters supporting compliance with environmental and occupational health requirements.

External safety systems: Receive and display status signals from external safety systems (e.g. fire detection) for operational awareness; BMS shall not perform direct fire safety control functions.

Hardware compliance: BMS hardware components comply with applicable environmental regulations.

OHS Act compliance: Support compliance with Occupational Health and Safety Act as applicable to facility.

Safety override and emergency control: Respond to safety/emergency conditions including external safety signals; execute predefined safety control actions for protection of personnel, equipment, facility.

Manual override security: Secured access, role-based restrictions, logging of user/system/duration, notification of relevant personnel.

Automatic resumption: Defined criteria, timing, manual confirmation for resuming automatic control after override; conditional on resolution of conditions and restoration of normal operation.

Equipment protection: Automatic sequencing and interlocking to prevent damage; operation only when conditions and interlocks satisfied.

Fault handling: Detection of faults, communication failures, abnormal conditions; alarms and predefined control actions for safe operation and minimal disruption.

Energy management: Monitor, analyse, optimise energy consumption; insights into usage patterns; automated controls to minimise waste; monitor energy usage for HVAC and integrated utilities; identify abnormal consumption trends; facilitate optimisation.

Environmental control: Temperature control ±0.5°C; humidity control ±2% RH; differential pressure monitoring per facility design; supply/return airflow monitoring per HVAC design; ACPH monitoring for classified areas.

Ventilation: Monitor and control supply/return air volumes and ACPH; ventilation control accuracy per HVAC design.

Pressure cascade: Monitor and control differential pressure relationships between classified areas; alarms and control actions on loss of cascade.

Regulatory: SANS 204, ISO 50001:2018, SANS 10400, OHS Act, local/regional environmental regulations.

Effluent integration: LA effluent system and chemical/industrial effluent system integration for coordinated monitoring, control, alarm management.

Data retention: Historical data, alarms, events, trends retained per NTP and GMP requirements.

Definition: 'Shall' indicates a mandatory requirement; the supplier or system shall comply without exception.

General: BMS shall provide reliable monitoring, control, alarming, trending, and recording for facility environmental conditions, utilities, and associated systems required for GMP operation; scalable for future expansion; support centralized supervision and distributed control architecture.

Hardware: Controllers offering flexible, powerful, scalable solutions for HVAC and building systems integration; reliable components; support multiple protocols (BACnet, Ethernet, Modbus, LonWorks); sufficient processing capacity; modular expandability.

Communication: Industry-standard protocols including BACnet/IP (primary) and others as required; protocol requirements per equipment interface defined in Functional Design Specification (FDS); integration with HVAC, differential pressure, compressed air, nitrogen, UPS/generator, LA effluent, chemical/industrial effluent systems; reliable network infrastructure; synchronised system time via facility IT NTP with alarm on loss of sync.

Performance: Monitoring and control within defined operational accuracy limits; temperature ±0.5°C, humidity ±2% RH; airflow values displayed as measured; differential pressure and airflow accuracy per design documentation; stable reliable control.

Data management: Secure storage/retrieval of historical data, alarms, events, trends; configurable logging intervals and retention per GMP/operational requirements; export capability for engineering, maintenance, compliance.

Alarm management: Alarms for environmental deviations, equipment faults, communication failures, critical events; configurable priorities, acknowledgement, handling per facility alarm philosophy; historical alarm records retained.

Compliance: ASHRAE 135, ISO 16484, SANS 10142, OHS Act, local environmental regulations, IEC 62443, NIST Cybersecurity Framework, HTTPS/TLS, periodic vulnerability assessments.

Security: RBAC aligned with operational responsibilities; audit trails for critical actions, configuration changes, overrides; GMP-critical parameters identified via risk assessment with appropriate validation and access control.

Operational: User roles (administrators, operators, maintenance); comprehensive training (manuals, on-site sessions, maintenance training); scheduled maintenance with minimal disruption; vendor technical support during warranty.

Documentation: User manuals, installation/configuration guides, maintenance procedures, as-built documentation (wiring, network topology, equipment layouts, lists, I/O), system configuration documentation (parameters, network config, backup/recovery, user access, backup files, controller configs, graphics, parameter databases, credentials).

Project implementation: Timeline defined in tender documentation (not in URS); commissioning/validation plan with IQ/OQ/PQ, phased commissioning, coordination; change management per NTP-PRG-0732.

Supervisory system: Centralized visualization, monitoring, alarm management, historical review, supervisory control; interface with distributed controllers via approved protocols; support virtualization, centralized administration, scalability.

GUI: Graphical interfaces on approved workstations; clear equipment status, alarms, process values, trends, operating modes; logical consistent navigation for rapid operator response.

Graphics: Standardized symbols, colour conventions, display philosophies; dynamic animations for equipment status; alarm conditions visually distinguishable.

Workstations: Operator, engineering workstations, approved client access; remote access controlled via approved cybersecurity/IT procedures; mobile/portable access subject to NTP approval and cybersecurity requirements.

Electronic records: ALCOA+ compliance, compliant electronic signatures, protection against unauthorised modification, secure retention.

User account management: Controlled per NTP IT/cybersecurity requirements; password policies, lockout rules, session timeouts, admin controls per approved policies; unique individual accounts, no sharing.

RBAC: Access restricted per approved roles; permissions restrict configuration changes, overrides, alarm management, engineering functions; role definitions documented and approved.

Backup/disaster recovery: Automated backup of configuration, historical data, software, databases; restoration procedures tested and documented; recovery of validated functionality and records within business continuity requirements.

Server/virtualization: Virtualised servers in NTP IT-approved environment; VM configs, resources, redundancy defined in detailed design; IT domain and cybersecurity integration per approved requirements.

Network architecture: Secure reliable communication; segmentation, firewalls, secure protocols per IT/cybersecurity requirements; remote connectivity restricted to approved secured methods.

Computerized system lifecycle: Requirements defined in Section 7.19 (not fully extracted).

Configuration and change management: Requirements defined in Section 7.20 (not fully extracted).

Redundancy and high availability: Requirements defined in Section 7.21 (not fully extracted).

Third-party integration: Requirements defined in Section 7.22 (not fully extracted).

No tender-specific evaluation criteria, scoring methodology, minimum thresholds, or preference point system details found in the provided document. The document is a User Requirements Specification (URS) for the BMS system, not a tender evaluation document. Evaluation criteria would be contained in the separate tender documentation referenced in Section 7.4.1.

Nb: failure to provide / or comply with any of the above particulars may render the bid invalid.

The closing date is 2026-09-16. There are no specified mandatory briefing or site visit dates.

The contact person for bidding procedure enquiries is Mr Buyani Nsibande, with a telephone number of 012 305 6072 and an email address of [email protected].

Bids must be delivered by the stipulated time to the correct address. Late bids will not be accepted for consideration. All bids must be submitted on the official forms provided. The bid submission address is not specified, but bids can be deposited in the bid box situated at the specified street address. The closing time is 11:00.

The evaluation criteria include a preference point system, with a maximum of 80 or 90 points allocated for price. The applicable preference point system for this tender is either the 90/10 or 80/20 preference point system, to be determined by the organ of state. Points will be awarded for price and specific goals.

The technical specifications include the modification of an existing structure for the establishment of a Radioiodine Active Pharmaceutical Ingredient (API) facility. The bidder must provide professional engineering services (design and management) for the project.

The financial requirements include the pricing format, with the bid price including all applicable taxes. The bidder must also provide a valid tax clearance certificate and comply with the B-BBEE requirements.

The compliance requirements include registration on the Central Supplier Database, a valid tax clearance certificate, and compliance with the B-BBEE requirements. The bidder must also submit their unique personal identification number (PIN) issued by SARS.

The Parties choose the addresses set out in SLA as their domicilium citandi et executandi for all purposes under this Agreement.

The Service Provider's performance shall be evaluated based on the deliverables and milestones set out in the Project Plan and Schedule of Deliverables.

Supply of goods or works or rendering of services

NECSA shall pay the Service Provider Fees as set out in the Pricing Schedule for full and complete performance of the Services. Payment shall be made within thirty (30) days after receipt of a correct monthly statement.

The Service Provider shall ensure that all its employees or agents who may be privy to any information, reports, data and related matter are well informed and aware of the contents and legal implications of Section 51 of Nuclear Energy Act, 1999.

The contract shall be governed by and construed in accordance with the laws of the Republic of South Africa. The Service Provider shall indemnify NECSA against all loss or damage arising from the performance of the Services.

NECSA shall pay the Service Provider the Fees set out in the Pricing Schedule, after the Services have been fully performed and completed.

Tender seeks appointment of a professional engineering services firm for design and management of the modification of Building P1900 at the NECSA Complex (Elias Motsoaledi Street Extension, R104 Pelindaba, Brits, Madibeng Municipality, North West Province, 0240) to establish a Radioiodine Active Pharmaceutical Ingredient (API) facility producing non-sterile I-131 API in liquid form. Project reference: NTP-PRJ-22/001. Scope covers full project lifecycle from inception to close-out across six stages, with compliance to cGMP (SAHPRA, PIC/S), ISO 14644, and nuclear regulatory standards.

Closing date: 16 September 2026 at 11:00 (from tender record). No compulsory briefing, site visit, or clarification deadline stated in the document.

No named SCM or technical contacts, emails, or phone numbers provided in the document. Facility location: Building P1900, NECSA Complex, Elias Motsoaledi Street Extension (Church Street West), R104 Pelindaba, Brits Magisterial District, Madibeng Municipality, North West Province, 0240.

The service provider must be a professional engineering firm registered with the Engineering Council of South Africa (ECSA) in terms of the Engineering Profession Act, capable of delivering multi-disciplinary design (architectural, structural, mechanical, electrical, HVAC, fire protection) and project management for nuclear/pharmaceutical facilities. Must demonstrate compliance with Necsa QMS requirements for external design organisations (SHEQ-INS-0234). Must have capacity to produce designs meeting cGMP, SAHPRA, PIC/S, and ISO 14644 standards for radioactive API manufacturing. No explicit CIDB grading, B-BBEE level, or financial turnover thresholds stated in the document.

Scope: Modification of an existing structure (Building P1900, NECSA Complex, Elias Motsoaledi Street Extension, R104 Pelindaba, Brits, Madibeng Municipality, North West Province, 0240) for a Radioiodine Active Pharmaceutical Ingredient (API) facility producing non-sterile I-131 API in liquid form.

Design must comply with cGMP principles per SAHPRA, PIC/S, ISO 14644, and applicable national/international standards.

Services cover six project stages:

• Stage 1: Inception/Initiation — assess requirements, evaluate URS (NTP-SPE-4162, NTP-SPE-4168), inspect site, advise on surveys/investigations, conclude agreement. Deliverables: agreed scope, signed agreement, site/functional report, schedules of surveys/consents, Inception Report.
• Stage 2: Concept and Viability/Preliminary Design — develop concept/preliminary design for HVAC, electrical, lighting, finishes, process systems; establish design criteria and regulatory requirements; prepare process/preliminary designs, cost estimates. Deliverables: concept design criteria, concept/preliminary designs (PDF/drawing), quality assessment report, schedules, process design, preliminary cost estimates, Concept Report.
• Stage 3: Design Development/Detail Design — finalise design, outline specifications, cost plan, BOQ; prepare architectural, MEP, laboratory casework, HVAC, fire safety drawings; submit to authorities for approval. Deliverables: design development drawings (CAD/PDF), outline specifications, authority submissions, BOQ, Design Development Report.
• Stage 4: Design Documentation and Procurement — prepare procurement/construction documentation, specifications, working drawings, tender documents; assist in tender evaluation and due diligence inspections. Deliverables: specifications, services coordination, construction-ready drawings (CAD/PDF), budget cost, tender documentation, evaluation/recommendation report with due diligence, priced contract documentation, Design Documentation Report.
• Stage 5: Works, Contract Administration and Inspection — manage construction contracts, coordinate with NTP operations, issue construction documentation, inspect works, adjudicate claims, prepare payment valuations, witness tests, approve contractor drawings, issue contract instructions, arrange statutory certificates. Deliverables: cash flow schedules, construction documentation, drawing register, contract instructions, payment valuations, progressive/final accounts, practical completion/defects list, statutory certificates, Works Completion Report.
• Stage 6: Handover and Close-Out — verify defect rectification, approve valuations/certificates, procure O&M manuals/warranties/as-builts, finalise accounts. Deliverables: payment valuations, completion lists, O&M manuals/warranties, as-built drawings/documentation, final accounts, Close-out Report.

Key referenced documents: NTP-SPE-4162 (Requirements Specification), NTP-SPE-4168 (BMS User Requirements), SHEQ-INS-0234 (Necsa QMS for External Design Organisations), ISO 14644, ECSA Guideline Scope of Services and Professional Fees (Gazette 52691, 16 May 2025).

Service provider shall render engineering design and project management services for NTP-SPE-4162 Rev 2 and NTP-SPE-4168 Rev 1 across six stages: (1) Inception/Initiation — requirements assessment, URS evaluation, site inspection, agreement conclusion; (2) Concept and Viability/Preliminary Design — concept/preliminary design development, regulatory criteria establishment, process design, cost estimation; (3) Design Development/Detail Design — detailed design, specifications, BOQ, authority submissions; (4) Design Documentation and Procurement — procurement/construction documentation, tender preparation, evaluation support; (5) Works, Contract Administration and Inspection — construction management, quality inspection, financial administration, statutory compliance; (6) Handover and Close-Out — defect verification, documentation handover, final accounts. Each stage requires NTP approval of stage report to proceed. Virtual or in-person project meetings required throughout.

Service provider must be a professional engineering firm registered with ECSA under the Engineering Profession Act. Must demonstrate capability in multi-disciplinary design (architectural, structural, mechanical, electrical, HVAC, fire protection) and project management for nuclear/pharmaceutical facilities. Must have experience with cGMP, SAHPRA, PIC/S, ISO 14644 compliance for radioactive API manufacturing. Must comply with Necsa QMS requirements for external design organisations (SHEQ-INS-0234). Key personnel qualifications not specified in the document.

Service provider must comply with SHEQ-INS-0234 (Necsa QMS Requirements for External Design Organisations). Must prepare a Design and/or Project Quality Plan before design commencement covering: purpose/goals/scope of design programme; design phases, activities, tasks, deliverables; project organisation (roles, responsibilities, staffing); interface controls (review, approval, release, distribution, revision of design information); communication methods (document status, outstanding items, verbal confirmation); design inputs/constraints (user/process requirements, engineering procedures, QA requirements, regulatory requirements, codes/standards, methodologies); design outputs/documents per phase; design review/verification/validation activities per NTP-SPE-4162 Section 7.11 and NTP-SPE-4168; safety/quality/technical assessments; risk management approach; design programme/schedule (milestones, submissions, reviews, approvals); document management (numbering, version control, checking, review, approval, issue status, distribution, retention, retrieval); document issue stages (Concept, IFD, IFC); progress review process; change-control process; issue/action/deficiency/punch-list tracking; vendor documentation review/approval/use; compliance monitoring; controlled document maintenance with review/update/approval at appropriate stages. Must also comply with life-cycle requirements in NTP-SPE-4162 Section 7.11 and NTP-SPE-4168.

Pricing deliverables required at multiple stages: Stage 2 — preliminary cost estimates and life cycle costs; Stage 3 — detailed construction cost estimates as Bill of Quantities (BOQ); Stage 4 — budget construction cost and priced contract documentation; Stages 5-6 — schedules of predicted cash flow, payment valuations, progressive and final accounts. No specific pricing schedule format, rate structure, or payment terms (e.g., ECSA fee scale, lump sum, time-based) stated in the document.

Pricing format not explicitly stated in the document. Deliverables include preliminary cost estimates (Stage 2), detailed construction cost estimates as Bill of Quantities (Stage 3), budget construction cost and priced contract documentation (Stage 4), schedules of predicted cash flow and payment valuations (Stages 5-6). No bond, guarantee, insurance, or retention percentages specified.

Mandatory professional registration: Engineering Council of South Africa (ECSA) registration in terms of the Engineering Profession Act.

Quality compliance: Must comply with SHEQ-INS-0234 (Necsa QMS Requirements for External Design Organisations) and prepare a Design and/or Project Quality Plan before design commencement.

Design standards: cGMP (SAHPRA, PIC/S), ISO 14644 (cleanrooms), and applicable nuclear/pharmaceutical regulatory requirements.

No explicit CSD registration, tax clearance, B-BBEE level, CIDB grading, CIPC registration, or local content percentages stated in the document.

No specific health and safety requirements, OHS plans, or HSE compliance details stated in the document beyond general contractor obligation to comply with applicable health, safety, environmental and statutory requirements during construction (Section 6.4). Radioactive iodine (I-131) hazard noted: emits ionising radiation (beta/gamma), presents external and internal radiation hazard when inhaled/ingested. Facility design must address radiological safety per cGMP and nuclear regulatory requirements.

Contract structured across six stages with stage-gate approvals by NTP. Stage completion requires NTP approval of stage reports (Inception, Concept, Design Development, Design Documentation, Works Completion, Close-out). Service provider responsibilities include contract administration, financial claim adjudication, contract instruction issuance, and coordination with NTP operations to minimise disruption. Statutory certificates (e.g., Electrical Certificate of Compliance) and as-built documentation required at handover. Final accounts and Close-out Report conclude the appointment. No specific contract duration, termination clauses, liquidated damages, or penalty provisions stated in the document.

Client (NTP) responsibilities: provide project brief, requirements, funding, information; appoint/manage service providers; give approvals/decisions within required timeframes; ensure legislative/policy/procurement compliance. Project Manager (NTP and Service Provider): manage/coordinate project within scope/budget/programme; coordinate stakeholders; monitor cost/programme/quality/risks/progress; manage reporting/meetings/documentation. Service Provider: deliver professional/technical services per Scope; prepare designs/specifications/reports/deliverables; ensure legislative/standards/professional compliance; provide technical advice, quality monitoring, procurement/construction/commissioning/qualification/close-out support. Contractor: execute works per contract/drawings/specifications; manage construction activities/labour/materials/subcontractors; comply with HSE/statutory requirements; maintain quality standards/testing/inspections; manage programme/report progress; rectify defects; maintain records; complete commissioning/handover/close-out.

No explicit evaluation criteria, scoring split (80/20 or 90/10), minimum functionality thresholds, or preference point system stated in the document. Evaluation appears to be based on mandatory compliance with ECSA registration, SHEQ-INS-0234 QMS compliance, and demonstrated capability for cGMP/nuclear/pharmaceutical facility design. Service provider assists NTP in evaluation and recommendation of construction tenders (Stage 4), including due diligence inspections of tenderers' recent installations.

Closing date: 16 September 2026 at 11:00 (South African Standard Time). No compulsory briefing or site visit dates stated in the available document.

No named SCM or technical contacts, emails, phones or submission address are stated in the available text.

Returnable forms: SBD 1, SBD 3.3, SBD 4, SBD 6.1, SBD 8, SBD 9, and Authority to Sign/Board Resolution. Local production and content declaration (SBD 6.2) may apply if local content thresholds are specified in the full tender.

Firm must be registered with ECSA and hold valid professional indemnity insurance. Key personnel must include a Pr.Eng. with nuclear facility experience and a radiological protection specialist registered with the South African Radiation Protection Association. Company must be CSD-registered, tax-compliant, and hold a valid B-BBEE certificate. Demonstrated experience in at least two nuclear-licensed facility projects and two GMP API facility projects in the last 10 years.

Technical drawing I5381-00-00 showing facility layout for radiological GMP classified areas including Hot Cells, Production Zones, Maintenance Areas, Change Rooms, Airlocks, Material Pass, Waste Storage, Concrete Waste Area, Roller Conveyer Systems, Crane zones, Non-radiological Cleaning Store, Receiving & Packaging Area, Truck Receiving Area, and Contamination Control zones.

Pricing format: professional services pricing schedule (SBD 3.3). No bond, guarantee, insurance amount, payment terms or financial capacity thresholds are stated in the available text.

Contamination Control zones (Red/White/Blue/Green classification), Hot Cells, Production Zones, Maintenance Areas, Change Rooms, Airlocks, Material Pass, Waste Storage, Concrete Waste Area, Roller Conveyer Systems, Crane zones, Non-radiological Cleaning Store, Receiving & Packaging Area, Truck Receiving Area.

The document defines high-level requirements for the production of non-sterile activation Iodine-131 Active Pharmaceutical Ingredient (API) in a new manufacturing facility located in Building P1900 on the Necsa site. The facility will receive irradiated targets from the SAFARI-1 research reactor via shielded transfer containers, process them in hot cells, and package the product into shielded containers. The hot cell production line is excluded from scope and will be supplied by a third-party specialist.

The facility is classified as a Direct Impact (quality critical) system under the ISPE Commissioning and Qualification Guideline, Vol 5, 2nd Ed, and therefore requires commissioning and qualification. Minimum testing requirements include Design, Installation, Operational and Performance Qualification. The scope of qualification is determined through a risk-based approach, with testing levels commensurate with risk to product quality.

The facility is to be located in Building P1900 on the Necsa site at R104, Pelindaba, Brits Magisterial District. It will produce non-sterile activation Iodine-131 Active Pharmaceutical Ingredient (API). The hot cell production line (hot cells and associated in-cell processes) is excluded from scope and will be supplied by a third-party specialist. The facility must include the following areas with adequate segregation: Storeroom, Sampling and Preparation Area (incl. Weighing Booth), Target Welding Area, Production Area, Hot Cell Maintenance/Service Area, Packaging Area, Receiving and Dispatch Area, Radiological Effluent Area, Chemical/Industrial Effluent Area, and Manufacturing Facility Ancillary Areas. Radiological areas must be separated from non-radiological areas and zoned per SHEQ-INS-8030. Hazardous Chemical Substances (HCS) areas must be zoned per SHEQ-INS-7010. The production area floor must support 4 hot cells weighing a total of 170 tons. The Hot Cell Maintenance/Service Area must allow storage of up to 6 concrete drums (each up to 3 tons) for up to 90 days, and accommodate a 4-ton truck for receiving targets and removing drums. The dispatch area must also accommodate a 4-ton truck. The facility must provide a dedicated area for collection and interim storage of HCS solid and liquid waste with easy access for the waste contractor. Occupied spaces must not experience noise levels above ANSI NC 50 due to HVAC system function.

The requirements specification is intended to facilitate prospective suppliers and design engineers in understanding needs and proposing a suitable design. It is not an exclusive approach; alternative suggestions are welcome. The consulting engineers are responsible for developing a facility, services, and systems design based on the requirements. The identification of omissions or additional cGMP and related requirements is mandatory and remains the sole responsibility of the consulting engineers.

The facility must be designed, constructed, commissioned, and qualified in accordance with Good Engineering Practice (GEP), current Good Manufacturing Practice (cGMP), and hazardous (chemical/radiological) material requirements. Compliance with the following is required: Hazardous Substances Act, National Environmental Management: Atmospheric Pollution Prevention Act, National Environmental Management: Waste Act, Occupational Health and Safety Act, National Building Regulations and Building Standards Act, ICH Q7, ISO 8573-1:2010, ISO 14644-1:2015, ISO 14644-3:2019, ISO 14644-4:2022, ISO 17873-2004, ISPE Baseline Guide: Commissioning and Qualification, ISPE Good Practice Guide: HVAC, PIC/S Guide to GMP (PE-009-17 Parts I & II and Annexes 1, 3, 15), SAHPRA GMP guidelines (SAHPGL-INSP-02_v9, SAHPGL-INSP-GMP-02_v1, SAHPGL-RDN-RN-13_v2), SANS 1186-1, SANS 7240-16, SANS 7240-19, SANS 10114-1, SANS 10400, SANS 10140, SANS 10142, and various NECSA SHEQ instructions (SHEQ-INS-0233, 0234, 1110, 1120, 1250, 2500, 5150, 7010, 7132, 7140, 8030, 8050, 8150, 8180, 8230, 8260, 8310, 8360, 8920). WHO TRS guidelines (No. 957 Annex 3, No. 1010 Annex 8, No. 1019 Annexes 2 & 3, No. 1025 Annex 2, No. 1044 Annex 2) also apply. The consulting engineers are responsible for identifying any additional cGMP and related requirements and for compliance with all South African laws and municipal by-laws.

The facility must comply with the Occupational Health and Safety Act and NECSA SHEQ instructions including SHEQ-INS-5150 (First Aid Officer and Facilities), SHEQ-INS-7010 (Zoning of facilities with hazardous chemical substances), SHEQ-INS-8030 (Classification and demarcation of radiological areas), SHEQ-INS-8050 (Radiological surveillance programme), SHEQ-INS-8150 (Access and Egress Control to Radiological Areas), SHEQ-INS-8180 (ALARA programme), and SHEQ-INS-8920 (Access Control to Necsa Sites).

The facility must comply with the National Environmental Management: Atmospheric Pollution Prevention Act, National Environmental Management: Waste Act, and NECSA SHEQ instructions for management of radioactive discharges to the atmosphere (SHEQ-INS-8230), radioactive effluent and discharge (SHEQ-INS-8260), and solid radioactive waste (SHEQ-INS-8360). Radiological areas must be separated from non-radiological areas and zoned per SHEQ-INS-8030.

The facility must be designed, constructed, commissioned, and qualified in accordance with GEP, cGMP, and hazardous material requirements. The consulting engineers must identify any additional cGMP and related requirements and ensure compliance with all South African laws and municipal by-laws. The facility must include areas for storeroom, sampling and preparation, target welding, production, hot cell maintenance, packaging, receiving and dispatch, radiological effluent, chemical/industrial effluent, and ancillary areas.

Qualification of the facility must include Design, Installation, Operational and Performance Qualification as minimum testing requirements. The scope of qualification is determined through a risk-based approach.