The difference
- Non-sterile. Made and packed to control particles and residues. It is not treated to remove microbes.
- Sterile. Treated, often by gamma irradiation, and supplied with a sterility claim and batch records.
Where each is used
| Area | Usually |
|---|---|
| Electronics, semiconductor, data hall | Non-sterile |
| Pharma support and gowning areas | Often non-sterile, depending on the grade |
| Aseptic and sterile filling areas | Sterile, for items that enter the critical zone |
| Medical device manufacture | Depends on the process and risk assessment |
How to decide
- Check the grade or class of the area.
- Check what your contamination control plan requires.
- Check what the item touches: surfaces, product or people.
- Ask your quality team to confirm.
What to ask the supplier
- Sterilisation method and the sterility assurance level, where claimed
- Batch documents and certificates
- Packaging type, for example double bagged
- Shelf life and storage conditions
Sterile items cost more. Use them where your quality system calls for them, not by default.
Keep reading
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