Appointment of professional engineering services firm for novatec-p (Tc-99m) generator production area and HVAC system upgrade

Open to professional engineering firms (local or international, but must comply with South African regulations). Must be a registered entity (registration number required) with the capacity to enter into a legally binding agreement. Proven experience in nuclear facility upgrades, HVAC systems, and adherence to industry-specific safety/quality standards is required. Must agree to POPIA terms, including data protection, confidentiality, and sub-operator management.

Compliance with the Protection of Personal Information Act (POPIA) is mandatory. Key requirements: Process personal information only on documented instructions from Necsa. Ensure all personnel processing personal information are bound by confidentiality. Implement technical and organisational measures to secure personal information. Do not engage sub-operators without prior written approval from Necsa. Assist Necsa in fulfilling data subject rights and compliance obligations. Delete or return all personal information to Necsa upon contract termination, unless legally required to retain it. Allow Necsa to audit compliance with POPIA. Adhere to the 8 conditions for lawful processing of personal information as per POPIA.

Project site address: Building P3000, NECSA Complex, Elias Motsoaledi Street Extension (Church Street West), R104 Pelindaba, Brits Magisterial District, Madibeng Municipality, North-West Province, 0240. No specific contact person, email, or phone number is provided.

Evaluation will focus on the following criteria:

• General:
• Applicant must be a registered professional engineering firm.
• Must have experience in cGMP, cleanroom design, and radiological facilities.
• Compliance with ECSA Professional Services Framework (Stages 1–6) is mandatory.
• Familiarity with NECSA/NTP standards and South African regulatory requirements is required.
• Proven track record in similar projects (e.g., pharmaceutical, nuclear, or radiopharmaceutical facilities).
• Technical:
• Expertise in HVAC systems for cleanrooms (ISO 14644, PIC/S Annex 1).
• Experience with radiological safety, containment, and ALARA principles.
• Ability to perform risk assessments (Quality Risk Management - QRM) and validation (Commissioning and Qualification - C&Q).
• Knowledge of materials compatible with cleanroom and radiological environments (e.g., stainless steel, non-combustible panels).
• Legal:
• Valid registration with relevant South African authorities (e.g., ECSA, SAQCC).
• Compliance with Broad-Based Black Economic Empowerment (B-BBEE) requirements, if applicable.
• No conflicts of interest with NECSA/NTP or other stakeholders.

Scope: Upgrade of the existing NovaTec-P Production Area and associated HVAC system in Building P3000 at the NECSA Complex.

• Purpose: Design, development, and qualification of a sterile radiopharmaceutical production area for NovaTec-P (Mo-99/Tc-99m) generators.
• Compliance: Must adhere to current Good Manufacturing Practice (cGMP), Good Engineering Practice (GEP), and radiological safety standards.
• Exclusions: Hot cell production line (hot cells and in-cell processes) is not part of this scope.
• Areas to be upgraded: Preparation Area (incl. Weighing Booth), Sterile Area, QC Elution Area, Decon and Clearance Area, Hot Cells Area, Emergency Shower Area, Personnel Change Rooms (Street Clothes, Grade D, C, B), and Material Transfer Areas.
• Classification: System is classified as Direct Impact (quality critical), requiring full commissioning and qualification (Design Qualification - DQ, Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ).
• Risk Assessment: Upgrade scope must be determined via a risk-based approach, with testing commensurate to risk levels.
• Supplier Responsibility: Must assess existing NovaTec-P Production Area and HVAC system to define upgrade requirements. Must identify omissions or additional cGMP/regulatory requirements not listed in the URS.
• Design Requirements:
• Layout must ensure logical material/personnel flow to avoid cross-contamination.
• Must include GMP-compliant conveyor/roller systems for safe handling of lead pots and radioactive generators.
• Must provide adequate space for equipment, storage, and safety measures (e.g., fire extinguishers, emergency showers).
• Surface finishes must be smooth, non-porous, cleanable, and resistant to chemicals/radiation.
• Cleanroom classifications: GMP Grade A/B/C/D (ISO 14644 Class 5/7/8) for various areas, with unidirectional airflow (UDAF) where required.
• Pressure cascades must comply with GMP (positive pressure) and radiological (negative pressure) requirements.
• Air change rates must ensure <20-minute cleanup from 'in operation' to 'at rest' states.
• HEPA filter leakage must be <0.01%.
• Radiological areas must comply with SHEQ-INS-8030 and other NECSA SHEQ instructions.
• Standards: Must comply with ISO 14644, PIC/S Annex 1, SAHPRA GMP guidelines, ISPE Baseline Guides, SANS standards, WHO TRS guidelines, and NECSA SHEQ instructions.

Mandatory compliance with the following:

• Good Engineering Practice (GEP) and current Good Manufacturing Practice (cGMP).
• South African legislation: Hazardous Substances Act, National Environmental Management Acts (Atmospheric Pollution Prevention, Waste), Occupational Health and Safety Act, National Building Regulations and Building Standards Act.
• International and local standards: ISO 14644 (Cleanrooms), ISO 17873 (Nuclear ventilation), PIC/S GMP (Part I, Annexes 1, 3, 15), SAHPRA GMP guidelines, ISPE Baseline Guides (C&Q, HVAC), SANS standards (fire, lighting, wiring, building regulations).
• NECSA SHEQ instructions: QMS for external design organisations, housekeeping, lighting, zoning of hazardous substances, surveillance programmes, hazardous waste management, radiological area classification, ALARA programme, ventilation for nuclear facilities, access control.
• WHO Technical Report Series guidelines for GMP, HVAC, and radiopharmaceuticals.
• Supplier responsibility: Must comply with all Republic of South Africa laws and municipal by-laws, even if not explicitly listed in the URS.

Returnable Documents:

• The bid must include all specified returnable documents. Failure to submit these documents may lead to disqualification.

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• The bidder must ensure all compliance documents are in order, but specific requirements are not detailed in the available text.

• Ensure all required returnable documents are completed and submitted.

• The document indicates a requirement for compliance checks, but specific details are not provided. An AI extraction of the full tender document is recommended to identify exact requirements (e.g., B-BBEE, tax, CIDB).

General:

• Must be a registered legal entity (implied by contract signing).
• Must comply with South African law and NECSA’s policies.
• Must provide a valid tax clearance certificate (Clause 29.3).

Technical:

• Proven expertise in nuclear facility upgrades (implied by project scope).
• Experience with HVAC systems in controlled environments.
• Ability to meet NECSA’s quality and safety standards (implied by warranties, Clause 26).

B-BBEE Compliance:

• Preference for Black Empowerment Companies in subcontracting (Clause 5).

Financial:

• Financial stability (implied by insolvency termination clause, Clause 20).
• Adequate insurance coverage (Clause 7).

Scope: Upgrade of the existing Novatec-P (Tc-99m) generator production area and HVAC system.

Deliverables: Defined in the Service Level Agreement (SLA) and accompanying annexures (e.g., Annexure B: Project Plan and Schedule of Deliverables).

Standards: Must meet NECSA’s quality, safety, and nuclear regulatory standards (implied by Clause 26 warranties and project context).

Capacity: Service Provider must demonstrate capability to execute nuclear facility upgrades and HVAC system enhancements in a controlled environment.

Pricing: Fees are as set out in the Pricing Schedule (Annexure E of the SLA).

Payment Terms:

• Payment is made only after services are fully performed, completed, and deliverables are accepted.
• Service Provider must submit a monthly statement, original invoice, and associated documents by the last day of the month.
• If documents are correct, payment is effected within 30 days of the statement date via electronic bank transfer.
• Travel and accommodation expenses may be reimbursed if agreed and invoiced separately.

Retention: NECSA may retain 10% of the contract value, payable within 3 months of receiving all goods/services and a certificate of acceptance.

Penalties: Delays in deliverables or performance may result in deductions from fees as per the Penalty Formula (Annexure D of the SLA).

Tax Compliance:

• Tax matters must be in order. No contract will be concluded with a bidder whose tax matters are not in order.
• Prior to award, NECSA must be in possession of an original Tax Clearance Certificate issued by SARS.

B-bbee:

• Preference for Black Empowerment Companies in subcontracting (Clause 5).

Insurance:

• Goods must be fully insured against loss or damage (Clause 7.1).
• Service Provider must have sufficient insurance cover for liabilities (Clause 7.2).

Legal and Regulatory:

• Compliance with South African law (Clause 27).
• Confidentiality and adherence to Section 51 of the Nuclear Energy Act, 1999 (Clause 16.1.4).