Cleanroom-Master®Annex 1 Ready
The KWP cleanroom film packaging from ISO-Class 5.
When purity and GMP are required.
Cleanroom-Master®
On various cleanroom production lines we produce LDPE film packaging in various designs:
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| flat film | flat tube | half tubing | gusseted tube |
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| film sections | flat bags | gusseted bags |
Applications:
- primary and secondary packaging for the medical and pharmaceutical industries
- laser and optoelectronics
- and aerospace
Characteristics:
- highly pure, from cleanroom production ISO-Class 5 / GMP class B
- lowest microbiological contamination (bioburden)
- free of cytotoxins
- bag-in-bag, double cleanroom packaging
- weldable
- sterilizable
Technical properties & raw materials:
- designs with and without additives e.g. slip or antiblock
- raw materials according to e.g. Regulation EU No. 10/2011, EG No. 1935/2004, EG 1907/2006, U.S. Food & Drug Administration (FDA) - Code of Federal Regulations, US Pharmacopeia (USP) & European Pharmacopoeia (Ph. Eur.)
Manufactured individually according to your requirements in design, quantity and format.
Advice:
If you cannot find a suitable option here, please contact us. We will be happy to work with you to find a solution that is right for you and your production process.
Lisa Weber
Industrial business management assistant
Phone: +49 (0) 6051 494 404-12
E-Mail: l.weber@kwp-gmbh.de
Sterile primary packaging for pharmaceutical products
Packaging as a critical component in your GMP production process. The KWP standard for pharmaceutical primary packaging!
Applications:
This highly pure and sterile cleanroom packaging is suitable for use in the most critical - the aseptic - production areas of your pharmaceutical production.
Characteristics:
Maximum safety for your products and the convenient all-in-one solution for successful approval of your GMP-compliant production processes, taking packaging into account as a critical component.
Cleanroom-Master® - pps packaging is:
- highly pure and sterile
- from cleanroom production ISO 14644-1, class 5 / GMP class B
- from raw materials according to European Pharmacopoeia (Ph. Eur.), US Pharmacopeia (USP) and suitable for direct active ingredient contact (API)
- free of cytotoxins
- manufactured in design, quantity and format individually according to your requirements
- in triple cleanroom packaging for transport inward transfer into the aseptic area of your production
- validated sterile products ISO 11137-2
- Annex 1 Ready
Our pharmaceutical production process under DIN EN ISO 9001:2015 and DIN EN ISO 15378:2018 - GMP for sterile pharmaceutical primary packaging.
KWP cleanroom light protection film
Applications:
This special light protection film is used for the transport and storage of particularly light-sensitive preparations such as cytostatics.
Characteristics:
- 100% UV protection in the wavelength range up to approx. 515 nm
- High light protection in the wavelength range above 515 nm
Cleanroom-Master® - UV/VIS - packaging is:
- highly pure
- from cleanroom production ISO 14644-1, class 5 / GMP class B
- bag-in-bag cleanroom packaging
- waterproof, liquid-tight
- flexible, stable
- weldable
- sterilizable
Safety through visibility:
Residual transmission in the area of visible light ensures the labels' readability while providing a high level of light protection.
- 100% UV protection
- content control possible
- protection and control in one step
Do you need advice on our products?
Please contact us. We look forward to hearing from you.
Contact a consultant