Objectives

The primary objective is to procure a semi-automatic liquid filling machine for the pharmacy at Osindisweni District Hospital to accurately decant and package liquid and semi-liquid medications. The procurement seeks to enhance pharmaceutical packaging precision, ensure compliance with provincial health technology standards, and align with government preferential procurement policies.

Scope

The scope covers the supply, delivery, installation, and commissioning of one (1) liquid filling machine at the specified hospital. It includes comprehensive training for clinical staff and hospital engineers, provision of all essential accessories and starter packs, and delivery of complete operational, maintenance, and service documentation. The supplier must provide a minimum twelve-month warranty covering parts, labour, and travel expenses, followed by a planned preventative maintenance agreement. Additional obligations include supplying calibration software, dedicated test equipment, ensuring long-term spare parts availability, and facilitating formal acceptance testing by the provincial Health Technology Services department.

Technical Requirements

• Semi-automatic operation with manual/automatic modes, utilising a positive displacement rotary gear pump coupled to a programmable controller.
• Filling range: 20 millilitres to 8 litres, with batch accuracy of ±0.5%.
• Compatible with diverse viscosities including alcohols, lotions, creams, gels, and syrups.
• Constructed with a type 316 stainless steel gear pump and full stainless steel enclosure; designed as a portable table-top unit.
• Equipped with adjustable motor speed control, variable cycle timer, non-return valve, and an easy-flush internal cleaning system.
• Electrical specifications: 220V ±10%, 50Hz single-phase AC, fused live and neutral, SABS-approved hospital-grade plug, and a minimum three-metre colour-coded mains cable.
• Mandatory compliance with IEC 60601-1 and 60601-1-2 medical electrical safety standards, CE certification, and electromagnetic interference protection.
• Refurbished or reconditioned units are strictly prohibited.
• Must supply two physical and two digital copies of operation, maintenance, and service manuals, including fault-finding guides, circuit diagrams, calibration protocols, and part numbers.
• Warranty commences upon successful commissioning and acceptance testing; equipment downtime extends the guarantee period day-for-day.
• Supplier must maintain a local service facility in KwaZulu-Natal or submit a formal subcontractor appointment letter.

Skills Requirements

Bidders must demonstrate proven expertise in medical and pharmaceutical packaging machinery. Required capabilities include OEM-certified technical personnel qualified to perform calibration, preventive maintenance, and complex repairs. Suppliers must possess or arrange for local service infrastructure in KwaZulu-Natal to guarantee timely response and support. Technical staff must be competent to deliver structured training programmes for both end-users and hospital engineering technicians, covering operational procedures, calibration protocols, and troubleshooting. Familiarity with South African medical device regulations, hazardous substance licensing (where applicable), and radiation control compliance is mandatory.

Notes on Unusual or Complicated Terms

• Health Technology Services – Clinical Engineering (H.T.S. – C.E.): A provincial department unit responsible for evaluating, accepting, and maintaining medical equipment. All supplied machines must undergo formal testing and receive certified operator/technician training by this unit before commissioning.
• Planned Preventative Maintenance Agreement: A contractual obligation requiring the supplier to provide scheduled servicing after the initial warranty expires to ensure ongoing equipment reliability and longevity.
• IEC 60601 Series Standards: International benchmarks for medical electrical equipment safety and performance, ensuring devices used in healthcare environments do not pose electrical shock, fire, or electromagnetic risks to patients or staff.
• 80/20 Preference Point System: A procurement scoring model where 80 points are allocated for competitive pricing and 20 points for socio-economic goals, specifically awarding full points to companies with at least 51% Black ownership.