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Classification of Washed Sterile Glass Vials

1. Risk level classification of Washed Sterile Glass Vials

n  Low-risk no-rinse sterile vials for oral medications, topical medications

n  High-risk no-rinse sterile vials for injectable drugs, high-risk drugs

2. Classification of packaging methods of Washed Sterile Glass Vials

n  Mode 1: Conventional soft PP box

200-500pcs per box, contact type discharge between glass vials in the box. Suitable for batch production line.

n  Mode 2: Individual Packaging

Individual packaging of 1 glass vial, suitable for application of 1 vial per use.

n  Mode 3: 5-10pcs small box packaging

5 or 10 pieces per box, non-contact between glass vials. Suitable for small batch application scenarios.

n  Mode 4: Rigid nest tray/nesting plate and tub/nesting box packaging (ISO11040)

30-120 pcs per box, non-contact between glass bottles. Suitable for filling lines where glass vials can be filled directly in the nest tray.

3. Material classification of Washed Sterile Glass Vials

n  Soda-lime glass

n  Low borosilicate glass

n  Neutral borosilicate glass

n  High borosilicate glass

4. Classification of the capacity ofWashed Sterile Glass Vials

n  Conventional capacity : 2ml~30ml (2R~30R)

n  Special capacity of customized: 0.5ml, 1ml, 50ml, 100ml

Conventional sizes are in accordance with ISO8362 standard, and customized special sizes are supported.

5. Glass vials production process classification

Tubular glass vial, molded glass vials

6. The internal surface treatment classification ofWashed Sterile Glass Vials

n  The inner surface of sterile bottles does not have any treatment.

n  The inner surface of no-wash aseptic vials is siliconized (cured by spraying silicone oil inside), which can improve the chemical stability of the inner surface of glass vials.

7. Washed Sterile Glass Vialsmouth is closed or not

n  The necks of Washed Sterile Glass Vials are not closed.

n  The necks of Washed Sterile Glass Vials are not closed with butyl rubber stoppers/silicone rubber stoppersand flip off caps/aluminum seals.

8. The internal pressure classification ofWashed Sterile Glass Vials

n  The RTU vial is not sealed, and the inside is regular air pressure.

n  The RTU vial is sealed, and negative pressure can be made inside the vial.

9. Whether the RTU vial is pre-filled with inert gas classification

n  The RTU vials have closed necks and are not pre-filled with specific gases.

n  The mouth of RTU vial is closed, and the vial is pre-filled with argon/nitrogen, which can better protect the liquid or powdered drugs to be filled at a later stage.

10. The production environment classification of Washed Sterile Glass Vials

n  Environment 1: Class C cleanroom production environment

In the class C purification workshop that meets the requirements of GMP specifications, the glass vials are cleaned with deionized pure water, dried in tunnel drying box to remove the pyrogens, and inspected and packaged automatically. Suitable for low-risk RTU vials.

n  Environment 2: Class C clean room + Class A clean area production environment

Glass vials are cleaned with injection water in GMP-compliant Class C area, dried in tunnel drying oven to remove pyrogen, and automatically inspected and packed in Class A area. Suitable for high-risk RTU vials.

11. Sterilization method classification of Washed Sterile Glass Vials

n  RTU vials are sterilized by dry heat (high temperature tunnel drying oven) during the production process.

n  RTU vials in the packaging is completed, the use of ethylene oxide sterilization or irradiation ray sterilization.General colorless glass bottles will become light amber after irradiation ray sterilization.