Procurement of new pharmaceutical-grade clean steam generators (csgs)

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{"name":null,"email":"[email protected]","phone":"012 522 1500","department":null,"address":"ENTS - minimum grading of 02 ME (Valid CIDB registration to be"}

Evaluation of Price and Preference

All Bids will be evaluated on a points system based on weighted average score for Price and

Preference as per Preferential Procurement Framework Act of 2000 (Act ).

Preference Point allocation – 80/20

Price / Preference Weighting percentage

Preference: 20%

OBP Onderstepoort Biological Points Evidence required Yes/No

Products will award preference

points as follows: Specific Goal

Total points 20

and serves as a claim form for preference points for specific goals.

1.1 The following preference point systems are applicable to invitations to tender

the 80/20 system for requirements with a Rand value of up to R50 000 000 (all

the 90/10 system for requirements with a Rand value above R50 000 000 (all

a) The applicable preference point system for this tender is the 90/10 preference point

b) The applicable preference point system for this tender is the 80/20 preference point

c) Either the 90/10 or 80/20 preference point system will be applicable in this tender.

1.3 Points for this tender (even in the case of a tender for income-generating contracts)

(b) Specific Goals.

The maximum points for this tender are allocated as follows

Specific goals 20

Total points for Price and SPECIFIC GOALS 100

this tender to claim points for specific goals with the tender, will be interpreted to mean

that preference points for specific goals are not claimed.

preferences, in any manner required by the organ of state.

OBP invites suitably qualified and experienced service providers to submit proposals for

the complete turnkey design, fabrication, supply, installation, testing, commissioning,

qualification support and documentation of two (2) new pharmaceutical-grade Clean

Steam Generators (CSGs). The equipment will be installed within OBP's

pharmaceutical manufacturing facility operating under current Good Manufacturing

Practice (cGMP). The clean steam generated shall be used for critical pharmaceutical

applications including, but not limited to:

• Sterilisation-in-Place (SIP)

• Autoclaves

• Vessel sterilisation

• Process equipment sterilisation

• Sterile manufacturing processes

• Other GMP critical applications

The proposed solution shall represent current international best practice and shall be

suitable for operation within a highly regulated pharmaceutical manufacturing

environment.

The successful bidder shall provide a complete turnkey solution, including all

engineering, design, statutory approvals, fabrication, factory testing, delivery,

installation, commissioning, validation support and training.

Project objectives

The objectives are to:

• Replace ageing clean steam generation assets with modern, highly reliable

systems.

• Improve clean steam quality and reliability.

• Reduce maintenance requirements.

• Improve energy efficiency.

• Improve operational redundancy.

• Ensure long-term spare parts availability.

• Ensure compliance with pharmaceutical GMP requirements.

• Ensure full compliance with applicable pressure equipment legislation.

• Facilitate future digital monitoring and predictive maintenance.

General scope of work

The bidder shall provide a complete turnkey package including:

• Process design

• Mechanical design

• Thermal calculations

• Pressure vessel design

• Fabrication

• Factory Acceptance Testing (FAT)

• Transportation

• Installation

• Piping modifications

• Structural supports

• Electrical installation

• Instrumentation

• Automation integration

• Commissioning

• Performance testing

• Validation documentation

• Operator training

• Maintenance training

• Final documentation

Nothing necessary for a fully operational installation shall be excluded because it was

omitted from this specification.

Design basis

Each Clean Steam Generator shall meet or exceed the following minimum design

requirements.

Mechanical Design Data

Shell Side

Parameter Requirement

Design Pressure 750 kPa

Design Vacuum -90 kPa

Maximum Allowable Working Pressure 750 kPa

Operating Pressure 600 kPa

Initial Hydrostatic Test Pressure 995 kPa

Maximum Design Temperature 175°C

Minimum Design Temperature 10°C

Operating Temperature 165.04°C

Corrosion Allowance 0 mm

Internal Volume 0.48 m3

Tube Side

Parameter Requirement

Design Pressure 900 kPa

Design Vacuum -90 kPa

Maximum Allowable Working Pressure 900 kPa

Operating Pressure 800 kPa

Initial Hydrostatic Test Pressure 1195 kPa

Maximum Design Temperature 180°C

Minimum Design Temperature 10°C

Operating Temperature 175.43°C

Corrosion Allowance 0 mm

Internal Volume 0.035 m3

Clean steam performance requirements

The bidder shall determine the required capacity based upon site demand. The

proposal shall include:

• Steam generation rate

• Peak demand

• Continuous demand

• Turndown ratio

• Response time

• Efficiency calculations

• Heat balance

The bidder shall perform a complete process study before final design.

Steam quality requirements

The clean steam produced shall comply with pharmaceutical industry expectations and

shall be suitable for:

• Sterile manufacturing

• Sip

• Sterilisation processes

Steam quality shall satisfy current GMP expectations including:

• Pyrogen free

• Non-condensable gases within accepted limits

• Dry saturated steam

• Free from contaminants

• Free from corrosion products

• Free from process chemicals

The bidder shall demonstrate compliance during commissioning.

Feed water requirements

The system shall operate using existing pharmaceutical purified water/RO water.

The bidder shall specify:

• Minimum feedwater quality

• Conductivity

• Silica limits

• TOC limits

• Hardness limits

• Temperature requirements

Any required pretreatment shall be identified.

Heating medium

Industrial steam shall be used as the heating medium. The bidder shall specify:

• Steam pressure

• Steam consumption

• Condensate generation

• Condensate return requirements

Design requirements

Preference shall be given to:

• Vertical construction

• Natural circulation design

• Low maintenance

• High efficiency

• Rapid start-up

• Compact footprint

• Low water hold-up volume

• High quality separation system

• Hygienic internal geometry

Materials of construction

Minimum requirements:

Pressure parts:

• Stainless Steel 316L

Product contact surfaces:

• Stainless Steel 316L

Surface finish:

Internal surfaces:

Ra ≤0.5 μm electropolished

External surfaces:

Brushed pharmaceutical finish.

Welding requirements

All welding shall comply with recognised pressure vessel codes. Requirements include:

• Orbital welding where applicable

• Full penetration welds

• Weld traceability

• Weld maps

• Qualified welders

• Qualified welding procedures

Pressure vessel requirements

The bidder shall provide:

• Design calculations

• Stress analysis

• Pressure vessel certification

• Hydrostatic testing

• Material traceability

• Nameplates

• Data books

Insulation

The entire unit shall be fully insulated.

Cladding:

• Stainless steel

Maximum external temperature:

Less than 50°C

Instrumentation

Minimum instrumentation shall include:

Pressure transmitters

Temperature transmitters

Level transmitter

Flow transmitter

Steam pressure gauges

Feedwater flow meter

Conductivity meter

Safety valves

Rupture disc (where required)

Vacuum breaker

Air vent

Steam trap

Drain valves

Sampling points

Control system

Each generator shall include a dedicated PLC.

Preferred manufacturers:

• Siemens

• Rockwell

• Schneider

• Abb

The system shall include:

• 15-inch HMI

• Alarm management

• Event logging

• Trend recording

• Batch reporting

• Historical data

• Recipe management

• Password protection

• User access levels

Scada integration

The system shall be fully compatible with the site's future SCADA architecture.

Pharmaceutical documentation

The contractor shall provide complete GMP documentation including:

Design Qualification support

Functional Specification

Hardware Design Specification

Software Design Specification

Factory Acceptance Test Protocol

Site Acceptance Test Protocol

Installation Qualification support

Operational Qualification support

Performance Qualification support

Material Certificates (3.1)

Surface finish certificates

Welding records

Calibration certificates

Pressure test certificates

Passivation certificates

As-built drawings

Operation manuals

Maintenance manuals

Spare parts manuals

Instrument data sheets

Valve schedules

Loop drawings

P&IDs

Electrical drawings

PLC backups

Software source code

Password documentation

Recommended spare parts list

Factory acceptance test (fat)

The bidder shall perform a witnessed FAT including:

Mechanical inspection

Pressure testing

Functional testing

Instrumentation verification

Control logic testing

Alarm testing

Interlock testing

Safety testing

Steam production demonstration

Documentation review

Site acceptance test (sat)

SAT shall include:

Mechanical completion

Electrical testing

Loop checks

Calibration

Commissioning

Steam production

Performance verification

Control testing

Alarm testing

Interlock verification

Emergency shutdown testing

Installation

The bidder shall provide:

Equipment removal (if applicable)

Rigging

Lifting plans

Foundations (where required)

Pipework

Valves

Supports

Electrical installation

Instrumentation

Cable trays

Cable management

Identification labels

Commissioning

Housekeeping

Training

Provide comprehensive training covering:

Operators

Maintenance personnel

QA & Validation personnel

Training manuals shall be supplied.

• At least five (5) pharmaceutical clean steam generator installations completed

within the last ten years.

• Reference sites with contactable clients.

• Demonstrated experience in GMP-regulated pharmaceutical environments.

• Local engineering, commissioning, and after-sales support capability.

• Availability of certified pressure vessel designers, qualified welding personnel,

automation engineers, and validation specialists.

the complete turnkey design, fabrication, supply, installation, testing, commissioning,

qualification support and documentation of two (2) new pharmaceutical-grade Clean

Steam Generators (CSGs). The equipment will be installed within OBP's

pharmaceutical manufacturing facility operating under current Good Manufacturing

Practice (cGMP). The clean steam generated shall be used for critical pharmaceutical

applications including, but not limited to:

• Sterilisation-in-Place (SIP)

• Autoclaves

• Vessel sterilisation

• Process equipment sterilisation

• Sterile manufacturing processes

• Other GMP critical applications

engineering, design, statutory approvals, fabrication, factory testing, delivery,

installation, commissioning, validation support and training.

• Process design

• Mechanical design

• Thermal calculations

• Pressure vessel design

• Fabrication

• Factory Acceptance Testing (FAT)

• Transportation

• Installation

• Piping modifications

• Structural supports

• Electrical installation

• Instrumentation

• Automation integration

• Commissioning

• Performance testing

• Validation documentation

• Operator training

• Maintenance training

• Final documentation

• Design calculations

• Stress analysis

• Pressure vessel certification

• Hydrostatic testing

• Material traceability

• Nameplates

• Data books

• Detailed technical proposal.

• Process description and design philosophy.

• General arrangement drawings.

• Preliminary Piping and Instrumentation Diagrams (P&IDs).

• Process flow diagrams.

• Equipment data sheets.

• Utility consumption schedule (industrial steam, purified water, electricity,

compressed air if applicable).

• Instrument list.

• Valve list.

• Control system architecture.

• PLC and HMI descriptions.

• Preliminary software functional description.

• Project execution methodology.

• Manufacturing schedule.

• Installation methodology.

• Commissioning plan.

• Validation support methodology.

• Inspection and Test Plan (ITP).

• Quality Assurance Plan (QAP).

• Risk assessment and mitigation strategy.

• Health, Safety and Environmental (HSE) plan.

• Project programme (Gantt chart).

• Commercial proposal, clearly itemised by engineering, equipment, installation,

commissioning, validation support, training, spares, and optional services.

• List of exclusions and assumptions.

Payment Terms: Payment terms: 30 days after statement

• Bidders must be registered on CSD (Central Supplier Data Base National Treasury) and be tax

complaint

• Government Procurement: all quotations of goods and services are subject to the General conditions of

Contract July 2010

I agree that the offer herein shall remain binding upon me and open for acceptance by OBP d

The bidder shall determine the required capacity based upon site demand. The proposal shall include

Steam generation rate

Peak demand

Continuous demand

Turndown ratio

Response time DOC NO.: PM-ME-002-F001 (EDITION 05) of 1

Efficiency calculations

Heat balance The bidder shall perform a complete process study before final design. STEAM QUALITY REQUIREMENTS The clean steam produced shall comply with pharmaceutical industry expectations and shall be suitable for

Sterile manufacturing

Sterilisation processes Steam quality shall satisfy current GMP expectations including

Pyrogen free

Non-condensable gases within accepted limits

Dry saturated steam

Free from contaminants

Free from corrosion products

Free from process chemicals The bidder shall demonstrate compliance during commissioning. FEED WATER REQUIREMENTS The system shall operate using existing pharmaceutical purified water/RO water. The bidder shall specify

Minimum feedwater quality

Conductivity

Silica limits

Hardness limits

Temperature requirements Any required pretreatment shall be identified. Requirements from the supplier (To be used to select the contractor)

SCM Administration requirements

SBD4 Bidders Disclosure - All suppliers MUST Complete, sign & submit the SBD4 declaration with their bid application

Bidder must submit CSD report and must be register on CSD Government Procurement: all quotations of goods and services are subject to the General conditions of Contract July 2010 Requirements from SCM department

All bidders MUST register their company (in advance) on the NEW OBP's E- Procurement portal, the link can be found on the official OBP website under supply chain.

Once bidders account registration is approved by the OBP Supply Chain, login credentials will be supplied, whereby bidders will be able to login and apply for opportunities. DOC NO.: PM-ME-002-F001 (EDITION 05) of 1

All open opportunities will reflect on the portal for bidders to part take in.

All required company documents, proposed submissions or additional requirements MUST be uploaded wit you bid application.

Any additional questions or Queries can be directed via email ([email protected] ) or telephone (012 522 1500), note NO SUBMISSIONS WILL BE ACCEPTED via EMAIL.

OBP reserves the right to cancel or re-advertise RFQ's (Request for quotes). SBD 4 BIDDER’S DISCLOSURE

Points Allocation: 90 points

B-BBEE Details: tpan Rd Onderstepoort, Pretoria, 0110

Evaluation of Price and Preference

All Bids will be evaluated on a points system based on weighted average score for Price and

Preference as per Preferential Procurement Framework Act of 2000 (Act ).

Preference Point allocation – 80/20

Price / Preference Weighting percentage

Preference: 20%

Price: 80 %

Total must equal: 100%

OBP Onderstepoort Biological Points Evidence required Yes/No

Products will award preference

points as follows: Specific Goal

DOC NO.: PM-ME-002-F001 (EDITION 05) of 1

Historically disadvantaged by unfair 10 A valid BBBEE Certificate showing at least

discrimination on the basis of Race 51% black ownership

Historically disadvantaged by unfair 8 A valid BBBEE Certificate showing at least

discrimination on the basis of Gender 30% women ownership

(women)

Historically disadvantaged by unfair 2 A doctor’s note confirming disability,

discrimination on the basis of disability confirmation of disability from the

Department of Labour, BEE certificate or

equivalent confirmation.

Total points 20

NB: Please note that if any of the above requirements is not submitted with the quote it will

be an immediate disqualification.

To appoint a supplierto provide the following item/s or service as per

Scope below.

Quantity Product/Item Code Specification

2 EA new pharmaceutical-grade DESIGN BASIS

Clean Steam Generators Each Clean Steam Generator shall meet or exceed

(CSGs) the following minimum design requirements.

Mechanical Design Data

Shell Side

Parameter Requirement

Design Pressure 750 kPa

Design Vacuum -90 kPa

Maximum Allowable Working Pressure 750 kPa

Operating Pressure 600 kPa

Initial Hydrostatic Test Pressure 995 kPa

Maximum Design Temperature 175°C

Minimum Design Temperature 10°

I CERTIFY THAT THE INFORMATION FURNISHED IN PARAGRAPHS 1, 2 and 3 ABOVE IS CORRECT.

Ra ≤0.5 μm electropolished

• Local technical support.

• Local spare parts availability.

• 24-hour technical assistance.

• Emergency call-out capability.

• Long-term product support (minimum 15 years).

• Software support and upgrade capability.

• Availability of preventive maintenance contracts.

28.

Minimum warranty:

• Twenty-four (24) months from commissioning

or

• Thirty-six (36) months from delivery

whichever provides the longer effective coverage.

Recommended spares

Provide:

Two-year operational spares

Five-year recommended spare parts list

Critical spare parts

Lead times

4.3. Name of company/firm...............................................................................

4.4. Company registration number: .....................................................................

4.5. Type of company/ firm

 Partnership/Joint Venture / Consortium

 One-person business/sole propriety

 Close corporation

 Public Company

 Personal Liability Company

 (Pty) Limited

 Non-Profit Company

 State Owned Company

[Tick applicable box]

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4.6. I, the undersigned, who is duly authorised to do so on behalf of the company/firm,

certify that the points claimed, based on the specific goals as advised in the tender,

qualifies the company/ firm for the preference(s) shown and I acknowledge that:

i) The information furnished is true and correct;

ii) The preference points claimed are in accordance with the General Conditions as

indicated in paragraph 1 of this form;

iii) In the event of a contract being awarded as a result of points claimed as shown

in paragraphs 1.4 and 4.2, the contractor may be required to furnish documentary

proof to the satisfaction of the organ of state that the claims are correct;

iv) If the specific goals have been claimed or obtained on a fraudulent basis or any

of the conditions of contract have not been fulfilled, the organ of state may, in

addition to any other remedy it may have –

(a) disqualify the person from the tendering process;

(b) recover costs, losses or damages it has incurred or suffered as a

result of that person’s conduct;

(c) cancel the contract and claim any damages which it has suffered

as a result of having to make less favourable arrangements due

to such cancellation;

(d) recommend that the tenderer or contractor, its shareholders and

directors, or only the shareholders and directors who acted on a

fraudulent basis, be restricted from obtaining business from any

organ of state for a period not exceeding 10 years, after the audi

alteram partem (hear the other side) rule has been applied; and

(e) forward the matter for criminal prosecution, if deemed necessary.

..............................................

Signature(s) of tenderer(s)

Surname and name: ................................................................

Date: ...............................................................

Address: ...............................................................

...............................................................

...............................................................

...............................................................

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• Replace ageing clean steam generation assets with modern, highly reliable

systems.

• Improve clean steam quality and reliability.

• Reduce maintenance requirements.

• Improve energy efficiency.

• Improve operational redundancy.

• Ensure long-term spare parts availability.

• Ensure compliance with pharmaceutical GMP requirements.

• Ensure full compliance with applicable pressure equipment legislation.

• Facilitate future digital monitoring and predictive maintenance.