Objectives

The primary objective of this tender is to procure an automated ampoule filling and sealing machine for SAVP, including comprehensive service and maintenance over a five-year period. The goal is to acquire a modern, compliant, and efficient pharmaceutical filling and sealing solution that meets regulatory standards and enhances operational capacity.

Scope

The scope encompasses the outright purchase of an automated ampoule filling and sealing machine, along with the provision of service and maintenance for five (5) years. The scope includes:

• Supply of the specified automated ampoule filling and sealing equipment.
• Installation, commissioning, and qualification documentation.
• Provision of training for operators and maintenance personnel.
• Ongoing maintenance, preventive and corrective, for five years post-installation.
• Compliance with Good Manufacturing Practice (GMP) standards, including RABS (Restricted Access Barrier System).

Technical Requirements

The technical specifications for the machine include:

• Fully automated ampoule filling and sealing system with RABS compatibility.
• Control panel located outside the LAF/RABS.
• Laminar Air Flow with RABS and glove testing instrument.
• Three filling heads/needles, in-feed peristaltic pump, and three piston pumps.
• Integrated particle counter with monitoring points in LAF and Grade B areas.
• Passive and active air sampling stations, active air sampler.
• Digital pressure gauges for HEPA filters and LAF air velocity.
• Production output greater than 20-25 ampoules per minute with ±1% filling accuracy.
• Sealing using acetylene and compressed air, with nitrogen flushing capabilities.
• Electrical characteristics: 230-320V, single-phase, 50Hz, overload protection.
• Contact parts made from Stainless Steel 316L; non-contact parts from Stainless Steel 304L.
• Safety features including emergency stop buttons and sensors for ampoule presence and rejection.
• Overall dimensions approximately 8.3m x 6.6m x 2.45m, weight not exceeding 6000kg.
• Provision for cleaning, maintenance, and qualification documentation, including risk assessments.

Skills Requirements

The successful bidder must demonstrate:

• Technical expertise in pharmaceutical equipment, specifically ampoule filling and sealing machinery.
• Capability to install, qualify, and validate GMP-compliant systems, including design, factory acceptance, installation, operational, and performance qualifications.
• Provision of comprehensive training for operators and maintenance staff.
• Experience in providing long-term service and preventive/corrective maintenance for complex pharmaceutical machinery.
• Ability to prepare and submit detailed documentation, including qualification protocols, risk assessments, and operation manuals.
• Compliance with ISO standards (ISO 3834-2021 for fusion welding and ISO 9001-2015 for quality management).
• Knowledge of occupational health and safety regulations, including safety testing and hazard assessments.

In summary, the tender seeks a technically proficient supplier capable of delivering a GMP-compliant, fully automated ampoule filling and sealing system with robust support and maintenance over five years, ensuring operational excellence and regulatory compliance.