- バリデーションガイド要約版
Validation - Accusil Platinum-cured silicone tubing
Accusil Platinum-cured silicone tubing is supported by an industry leading validation package and has full biopharmaceutical compliance with USP Class VI, Ph. Eur. 6.8 Chapter 3.1.9, ISO 10993 and FDA CFR 177.2600.
- 100% traceability with laser-etched part-number, lot number and use-by date
- Eight different sizes for filling between 0.1ml to more than 250ml
- Manufactured and packed in an ISO Class 7 cleanroom
Additional testing carried out includes extractables testing.
The full validation guide including additional information regarding test methods and actual test reports is available on request.
Accusil Platinum-cured silicone tubing, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the Accusil Platinum-cured silicone tubing compliance guide.
Both the full validation guide and the compliance guide can be requested by submitting the below form.
