USER REQUIREMENT SPECIFICATION FOR AMPOULES IN PHARMA

The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification (URS) to take through a successful Design Qualification (DQ).

1. User Requirement Specification for Automatic External Ampoules Washing, Drying & Self Adhesive Labelling Machine
2. User Requirement Specification for Ampoule Vertical Ultrasonic Washing Machine
3. User Requirement Specification for Ampoule Filling Machine
4. User Requirement Specification for Autoclave cum Bung Processor
5. User Requirement Specification for Clean in Place Sterilization in Place Module
6. User Requirement Specification for Depyrogenation Tunnel
7. User Requirement Specification for High Pressure High Vacuum Sterilizer
8. User Requirement Specification for Leak Testing cum Terminal Sterilizer
9. User Requirement Specification for Shrink Wrapping Machine
10. User Requirement Specification for Manufacturing Vessel (600 L)
11. User Requirement Specification for Manufacturing Vessel (1300 L)

A User Requirement Specification (URS) for pharmaceutical ampoules defines what the user needs from the ampoule container system to ensure product quality, patient safety, regulatory compliance, and manufacturability. It is used to qualify suppliers, approve packaging components, and support container-closure integrity and stability studies.

1) Intended use & product compatibility

• Product type: sterile injectable solution/suspension; route of administration.
• Compatibility requirements: ampoule material must not interact with formulation; limits for extractables/leachables, adsorption, and pH shift.
• Light protection needs (clear/amber) and labeling/printing requirements.

2) Ampoule type & design

• Material: Type I borosilicate glass (preferred for injectables) or justified alternative.
• Format: open/closed ampoule, OPC (one-point cut) / color-break ring, or scored neck.
• Nominal fill volume options (e.g., 1 mL, 2 mL, 5 mL, 10 mL) with defined brimful volume.
• Neck dimensions, tip shape, break force range, and anti-splinter performance.
• Cosmetic quality: limits for scratches, checks, stones, bubbles, cords, and dimensional tolerances.

3) Quality & regulatory compliance

• Compliance to pharmacopeial standards for glass containers (USP/EP/IP) including hydrolytic resistance.
• Supplier must provide DMF/CEP or equivalent documentation where applicable, CoA per batch, and change notification policy.
• GMP expectations for component manufacturing, inspection, washing (if supplied washed), and packaging.

4) Sterility and container-closure integrity (CCI)

• Ampoules must support validated sealing (flame sealing) with defined seal dimensions.
• CCI expectations: no leaks, no microcracks; suitable for helium leak/dye ingress methods as applicable.
• Cleanliness: particulate and cosmetic limits; endotoxin/bioburden limits if supplied ready-to-use.

5) Manufacturing/packaging performance

• Must run on filling line at target speed with acceptable reject rate.
• Thermal shock resistance suitable for terminal sterilization (if applicable).
• Compatibility with washing, depyrogenation tunnel, and handling systems.

6) Packaging, logistics, and labeling

• Tray/nest specifications, protection during transport, and storage conditions.
• Traceability: lot coding, supplier identification, and sampling plan (AQL).

7) Documentation & acceptance

• Drawings, specifications, test methods, stability/compatibility data, and agreed incoming inspection plan.