PHARMACEUTICALControlled Environment Technologies
Industry
Pharmaceutical
Contamination control strategy, gowning and consumables for classified areas in pharmaceutical manufacturing.
Datasheet per part number
Standards referenced
Recurring consumption
Sterile medicines manufacturing is governed today by one underlying idea: the contamination control strategy. It is not a list of approved products; it is a document explaining how every element of the process — consumables included — contributes to the product reaching the patient sterile.
Products for this industry
VANTERIS Polyester Wipe 9 × 9 inVTN-WP-PES-LS-999 × 9 in (228.6 × 228.6 mm)
VANTERIS Sticky Mat 24 × 36 in, BlueVTN-MAT-PE-STK-2436-BLU24 × 36 in
VANTERIS Beard Cover 18 in, WhiteVTN-AP-PP-BRD-UNI-WHT18 in
VANTERIS Sticky Mat 26 × 45 in, BlueVTN-MAT-PE-STK-2645-BLU26 × 45 in
Typical challenges
- Microbiological load in the filling zone
- Wiper compatibility with disinfectant rotation
- Material transfer through airlocks
- Consumable qualification and change control
Reference standards
| EU GMP Anexo 1 | Manufacture of sterile medicinal products; grades A-D and contamination control strategy. |
|---|---|
| ISO 14644-1 | Classifies air cleanliness by particle concentration. |
| USP <797> | Pharmaceutical compounding of sterile preparations. |
| USP <800> | Handling hazardous drugs in healthcare settings. |