Fume hood & bsc validation, hepa filter replacement – RFQ in western cape

Closing date and time: 28 October 2026 at 16:00

Date issued: 13 October 2026

Service commencement: as soon as possible after award

Contract period: 3 years with bi-annual validation (every 6 months)

No compulsory briefing or site visit mentioned

Enquiries (both technical and SCM):

• Email: [email protected]
• Telephone: 021 843 1000
• Fax: 021 843 3525
• International dialling code: +27

Postal address:

PO Box 722

Somerset West

7129

South Africa

Delivery address:

iThemba LABS

ATT: SCM Department

Old Faure Road

Faure, 7131

Website: http://www.tlabs.ac.za

Submission method: email only to [email protected]

Closing: 28 October 2026 at 16:00

Delivery address: iThemba LABS, ATT: SCM Department, Old Faure Road, Faure, 7131

Returnable documents (all must be completed, signed and submitted):

• SBD 4 (Bidder's Disclosure): mandatory – discloses state employment and conflicts of interest
• SBD 6.1 (Preference Points Claim): mandatory for South African companies – claims B-BBEE specific goals points with supporting certificate or sworn affidavit
• CSD Summary Report: mandatory – proof of Central Supplier Database registration
• Pricing schedule: mandatory – completed for all three years, VAT inclusive
• Three references from reputable pharmaceutical companies for similar work: mandatory
• Manufacturer authorisation letter for HEPA filter distribution: mandatory unless bidder is the manufacturer

Price validity: minimum 60 days from closing date

Prices: firm and VAT inclusive

Late submissions: not accepted under any circumstances

CSD registration: compulsory – unregistered bidders not considered

Tax compliance: verified via CSD tax pin or SARS tax compliance status

Mandatory returnable documents:

• SBD 4 (Bidder's Disclosure) – signed and completed
• Pricing schedule – completed for all three years
• Three references from reputable pharmaceutical companies for similar work
• Manufacturer authorisation letter for HEPA filter distribution (not required if bidder is manufacturer)
• CSD Summary Report

Optional returnable document:

• SBD 6.1 (Preference Points Claim) – signed and completed with B-BBEE certificate or sworn affidavit (for local bidders claiming specific goals points)

Evaluation stages: administrative compliance, functionality, price, B-BBEE

Preference point system: 80/20 (80 points price, 20 points specific goals)

Specific goals allocation (20 points total):

• B-BBEE Status Level 1-3: 8 points
• B-BBEE Status Level 4-6: 6 points
• B-BBEE Status Level 7-8: 2 points
• At least 51% Black-owned: 3 points
• At least 51% Black female-owned: 3 points
• At least 51% Black youth-owned: 1 point
• At least 51% owned by People with Disabilities: 1 point
• EME or QSE: 4 points

Minimum qualifying score: not explicitly stated

Automatic cancellation: if all bids exceed R1,000,000

Award: highest points per PPPFA section 2(1)(f)

No award to non-tax-compliant bidders

Proof of specific goals claims required with bid; failure to submit means points not claimed

Scope: bi-annual qualification, validation, servicing and HEPA filter replacement for 3 years at Nuclear Medicine Department, iThemba LABS, Faure

Equipment quantities:

• 10 fume hoods (tested per ASHRAE 110 or ANSI/AIHA Z9.5)
• 4 laminar airflow units (LAFUs) (tested per EN 12469 and NSF 49)
• 3 biological safety cabinets (BSCs) (tested per EN 12469 and NSF 49, GMP Grade A per EU GMP Annex 1)

Standards: ISO 14644, NSF/ANSI 49, EN 12469, ASHRAE 110, ANSI/AIHA Z9.5, PICS GMP Guidelines, EU GMP Annex 1

Pre-assessment required before each validation to identify corrective actions

Remedial work as needed: air ducting, hardware (fans, lighting, screens, interfaces), HEPA filters

All remedial work documented in final validation report

Validation frequency: every 6 months

Fume hood tests: physical inspection (sash, ducting, fan, switches), face velocity at varying sash heights, airflow visualisation (video), monitor/alarm calibration

LAFU tests: physical inspection (sash, ducting, pressure gauges, fan, switches), non-viable particle counting, airflow velocity, airflow visualisation (video), differential pressure, filter integrity (leak), illumination, vibration, noise

BSC tests: physical inspection (sash, ducting, pressure gauges, fan, switches, monitor/alarm calibration), non-viable particle counting, airflow velocity, airflow visualisation (video), differential pressure, filter integrity (leak), noise

Particle counting: both 'at rest' and 'in operation' conditions

Documentation: company certification per ISO 14644 and NSF/ANSI 49; validation reports per equipment with serial number, location, dates, reference instruments with calibration dates, accreditation certificate, test specifications, data/averages; videos of airflow visualisation; protocol compliance; validation stickers with dates

References: minimum three from reputable pharmaceutical companies for similar work

HEPA filter authorisation: manufacturer letter for distribution unless bidder is manufacturer

Fume hood methodology (10 units):

Physical inspection: sash mechanism, ducting and fan motor defects, switches/lights/sockets.

Qualification testing: face velocity at varying sash heights, airflow visualisation with video evidence, monitor and alarm calibration.

LAFU methodology (4 units):

Physical inspection: sash mechanism, ducting/pressure gauges/fan motor defects, switches/lights/sockets.

Qualification testing: non-viable particle counting, airflow velocity, airflow visualisation with video, differential air pressure, filter integrity (leak) test, illumination/light intensity, vibration, noise level.

BSC methodology (3 units):

Physical inspection: sash mechanism, ducting/pressure gauges/fan motor defects, switches/lights/sockets, monitor and alarm calibration.

Qualification testing: non-viable particle counting, airflow velocity, airflow visualisation with video, differential air pressure, filter integrity (leak) test, noise level.

Particle counting in both 'at rest' and 'in operation' conditions.

All testing per specified standards (ASHRAE 110, ANSI/AIHA Z9.5, EN 12469, NSF 49, ISO 14644, EU GMP Annex 1).

Experience requirement: at least three references from reputable pharmaceutical companies where similar qualification/validation work was performed.

HEPA filter capability: authorisation letter from manufacturer for distribution of HEPA filters, unless bidder is the manufacturer.

Company certification: testing methods certified per ISO 14644 and NSF/ANSI Standard 49.

Quality standards: ISO 14644, NSF/ANSI 49, EN 12469, ASHRAE 110, ANSI/AIHA Z9.5, PICS GMP Guidelines, EU GMP Annex 1

Company certification required for testing methods per ISO 14644 and NSF/ANSI 49

Validation reports per equipment must include: serial number, location, validation date, follow-up date, reference instruments with calibration dates, accreditation certificate/logo/number, test specifications/ranges, data and averages

Airflow visualisation videos required for each fume hood, LAFU, BSC

Testing and documentation per NMD protocol

Validation stickers with completion and next validation dates

Pre-assessment before validation to allow corrective actions

All remedial work included in final report for audit trail

Particle counting in both 'at rest' and 'in operation' conditions for BSCs

Three-year pricing schedule with identical annual quantities:

1. Fume hood qualification – 20 per year
2. Laminar Airflow Unit qualification – 8 per year
3. Biological Safety Cabinet qualification – 6 per year
4. Primary downflow HEPA filter replacement – 14 per year (as required)
5. Secondary exhaust HEPA filter replacement – 14 per year (as required)
6. Motor fan replacement – 7 per year (as required)
7. Air ducting replacement – hourly labour rate (as required)
8. Additional line item (unspecified) – quantity and rate to be provided

Totals required per year (VAT inclusive) and grand total for three years (VAT inclusive)

Prices firm, VAT inclusive, valid 60 days

Pricing schedule: three-year schedule with identical quantities each year

Yearly quantities:

• Fume hood qualification: 20
• LAFU qualification: 8
• BSC qualification: 6
• Primary downflow HEPA filter replacement: 14 (as required)
• Secondary exhaust HEPA filter replacement: 14 (as required)
• Motor fan replacement: 7 (as required)
• Air ducting replacement: hourly labour rate (as required)

Prices: VAT inclusive, firm, valid 60 days from closing

Currency: ZAR

Payment terms: 30 days from invoice receipt date

Advance payments: require payment guarantee approved by iThemba Labs Finance

Shorter payment terms: require payment guarantee or mutual agreement (7/14 days from delivery)

Firm delivery period must be indicated

Total price for three years (VAT inclusive) required

CSD registration: mandatory (www.csd.gov.za) – CSD Summary Report required

Tax compliance: mandatory – verified via CSD tax pin or SARS tax compliance status

B-BBEE: SANAS-accredited certificate or sworn affidavit required to claim specific goals points

SBD 4 (Bidder's Disclosure): mandatory – signed and completed

SBD 6.1 (Preference Points Claim): mandatory for South African companies – signed with B-BBEE evidence

References: three from reputable pharmaceutical companies for similar work – mandatory

HEPA filter authorisation: manufacturer letter for distribution – mandatory unless bidder is manufacturer

Company certification: testing methods per ISO 14644 and NSF/ANSI Standard 49

No CIDB grading required (non-construction)

No local content percentage specified

General Conditions of Contract (GCC) and Preferential Procurement Regulations 2022 apply

No specific health and safety requirements detailed beyond standard laboratory safety implied by fume hood/BSC validation work. The document focuses on equipment validation standards rather than occupational health and safety plans.

Contract period: 3 years with bi-annual service intervals

Payment terms: 30 days from invoice receipt

Advance payments: require finance-approved payment guarantee

Shorter payment terms (7/14 days): require payment guarantee or mutual agreement

Firm delivery period must be indicated

Late bids: not accepted

B-BBEE certificate or sworn affidavit required for specific goals claims

Mandatory RFQ requirements: failure to provide may disqualify

No changes to RFQ template/terms after closing

CSD Summary Report mandatory

Applicable legislation: PPPFA, Preferential Procurement Regulations 2022, General Conditions of Contract, special conditions if any

Fraudulent claims: disqualification, cost recovery, contract cancellation, restriction from state business up to 10 years, possible criminal prosecution

Evaluation process: Supply Chain Management evaluates for administrative compliance, functionality, price, and B-BBEE. Successful negotiations precede contract award.

Preference system: 80/20 (price 80, specific goals 20). Automatic cancellation if all bids exceed R1,000,000.

Award to highest points per PPPFA section 2(1)(f).

Tax compliance mandatory – verified via CSD tax pin or SARS TCS.

Specific goals points claimed via SBD 6.1 with B-BBEE certificate/affidavit; failure to submit proof means points not claimed.