With our class 5 clean room production facilities in accordance with DIN EN ISO 14644-1 at rest, we offer low-germ and low-particle production of our packaging material, guaranteeing "safety via extremely pure quality".
This specifically includes:
- Single-wound and tubular films
- Open-mouth and side gusseted mitred sealed bags
- Bottle-shaped bags
- Multiple-ply bags (Two- or three-ply-bags)
- Laminated aluminium bags with three sealing seams
- DuPont™ Tyvek® / HDPE bags with three side seals, autoclavable
- HeaderBags with a strip made with DuPont™ Tyvek®
- Packaging with DMF
Safety and quality
Tailored to customers' wishes, raw materials which are safe according to the FDA and LFGB can be used and specified for the material. All production and quality processes are oriented towards GMP. The advantages to you are clear.
- Low germ and low particle packaging
- The finished products retain the purity in which you have invested.
- Protection against external influences following production.
- No contamination of your own clean room facilities.
Use of CleanFlex® therefore ensures a high level of product safety and quality by adhering to the clean room chain from the start of production until the product reaches your customer.
Clean Room Production
Extrusion, printing and conversion machines are available in the completely encapsulated clean room to produce and develop these packaging materials. Our specially trained and motivated production teams are supported by our internal laboratory and testing facilities. The exclusive use of safe raw materials according to FDA and LMBG is equally a matter of course as GMP-friendly quality assurance at all levels.
On customer request B+K CleanFlex® packaging could be additionally treated by a sterilisation process. The particle-low and sterilised packaging is therefore ready-to-use for high-purity processes.
Solution Management CleanFlex®
phone +49 5481 920-734 oder 349
fax +49 5481 920-98734 oder 98349
B+K CleanFlex® patients safety
State: 20.09.2016 (146 Kb)
State: 25.01.2013 (1.14 MB)
DIN EN ISO 14644-1
State: 04.08.2020 (529 Kb)
ISO 15378:2017 Primary Packaging Materials for Medicinal Products
State: 08.01.2019 (129 Kb)