Service and Validation of Biohazard Safety Cabinet

add128-26-27

2026-06-11 09:00

2026-06-18 11:00

KwaZulu-Natal - Health

1 ME

Laboratory, Sampling and Analytical Equipment, Reagents and Consumables, Repair, Service and Maintenance of Machinery and Equipment

KwaZulu-Natal

Kwazulu Natal - Health

Kwazulu Natal - Health Tenders

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Service and Validation of Biohazard Safety Cabinet
Facility: Addington Hospital

Tender Summary

Objectives

The primary objective of this tender is to procure comprehensive services for the testing, validation, and certification of Biohazard Safety Cabinets (BSCs) and Laminar Flow Units (LFUs) located within the Pharmacy Department of Addington Hospital. The service aims to ensure product protection, operator safety, environmental control, and compliance with relevant healthcare and pharmaceutical standards.

Scope

The scope includes:

  • Servicing, testing, certification, and validation of Biological Safety Cabinets and Laminar Flow Units in the hospital pharmacy.
  • Bi-annual maintenance and validation (every 6 months).
  • Ad-hoc validation following relocation, filter replacement, or repairs.
  • Inspection of overall condition, internal and external surfaces, seals, lighting, electrical components, and controls.
  • HEPA filter integrity inspection and replacement if performance is below standard.
  • Airflow testing and balancing, including velocity measurements and adjustments.
  • Performance testing such as HEPA filter integrity, airflow, particle count, microbiological control, noise, lighting, and electrical safety.
  • Microbiological surface and air sampling where required.
  • Preparation of certification labels, reports, and compliance documentation.

Technical Requirements

The service must adhere to:

  • NSF/ANSI 49 - Biological Safety Cabinets
  • EN 12469 - Microbiological Safety Cabinets
  • ISO 14644 - Cleanroom Standards
  • ISO 14698 - Biocontamination Control
  • Good Pharmacy Practice (GPP) guidelines
  • Occupational Health and Safety Act (Act 85 of 1993)
  • Department of Health and SAPC requirements

All testing and validation procedures must be documented with detailed reports, certificates, and calibration data. The work must be performed without contaminating sterile areas and in coordination with pharmacy staff.

Skills Requirements

  • Certified technicians with proven experience in hospital or pharmaceutical environment validations.
  • Minimum CIDB grading of 1ME or higher.
  • Competency in cabinet validation, airflow measurement, microbiological sampling, and safety testing.
  • Ability to produce detailed validation reports, calibration certificates, and defect lists.
  • Knowledge of relevant standards and compliance requirements.
  • Provision of proof of previous successful similar projects (minimum 3 references).
  • Capability to prepare and submit safety files, certification labels, and comprehensive documentation.
This summary is AI generated. Download the tender documents for all the information.

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