Ultraclean Sterilizable Flexible Packaging
In the fast growing Biopharma market, the need for ultra clean sterile packaging is growing at a high speed, often driven by regulatory authorities and cGMP regulations.
Eliminating every risk of delivering a contaminated parenteral drug that might be hazardous to a patient's health or even his life is the key concern that drives these regulations.
The source for all your Cleanroom Packaging
With our Newform™ product line, we respond to this need by producing cleanroom packaging that meets these ever growing requirements.
Particle free packaging is obtained by our contamination control processes that focus on all different areas such as:
- airborne contaminants
- material borne contaminants
- microbial contaminants
- ionic contaminants
Starting from our own in-house extruded medical grade polymers in a highly controlled environment up to the conversion of the semi-finished products in our 2009, 2012 ATMI of the art ISO class 5 cleanrooms, we deliver high quality cleanroom packaging in a broad range of materials and shapes.
Our vertically integrated production facility assures quality and traceability throughout the entire process of selecting the best raw materials to the development and the final manufacturing of your customized particle free cleanroom packaging.
Our ultra clean packaging products are all sterilizable or can be delivered pre-sterilized by means of Gamma Irradiation.
All our cleanroom packaging is delivered with a certificate of conformance stating compliance toward our specifications on cleanliness, integrity and physical properties.
Furthermore, our sterile packaging is also delivered with a certificate of gamma irradiation.
Variety of materials:
- In-house extruded medical grade polymers (LDPE, HDPE, antistatic LDPE,...)
- Tyvek materials
- Barrier laminates
Variety of shapes:
- Half tubing
- Customized dye-cut shapes