This document certifies the product which manufactured by TS Filter in light of Current Good Manufacturing Practise standards.
This product is developed, produced and distributed according to the management system which is certified by ISO9001:2015.
Quality Assurance Criteria
Cleanliness
This filter product complies with the title 21 CFR, section 210.3 (b)(5)(6) and 211.72
❖ TOC & Conductivity
After controlled water flush, samples have less than 0.5mg (500 ppb) of carbon per litre, and the conductivity is less than 5.1 S/cm @ 25°c.
❖ Bacteria Endotoxins
A capsule aqueous extraction contains less than 0.25EU/ml
❖ Biosafety
All materials of this filter element meet the requirements of the current USP<87><88> for plastic class VI-121°c.
❖ Indirect Food Additive
All component materials meet the FDA indirect food additive requirements cited in 21CFR. All component materials meet the requirement of the EU regulation 1935/2004/EC. Contact suppliers for more info regarding the materials of construction.
❖ Animal Origin Statement
Based on the current information from our suppliers, all component material using in this product are animal-free.
❖ Bacteria Retention
This product has been successfully tested for retention of an acceptable challenge microorganism, using procedures described in TS Filter Validation Guides and correlated to ASTM Standard Test Methos ASTM F838, in conformance with the applicable requirements of the FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (September 2004).
❖ Lot Release Criteria
This manufacturing lot was sampled, tested and released by TS Filter Quality Assurance.
❖ Integrity Testing
Each filter element has been tested by TS Filter quality assurance based on the below standards, then release.
Integrity Test Standard (20°c):
Bubble Point (BP)
Diffusion Flow (DF)
Or Water Intrusion (WI)
Note: BP and DF should be tested after the filter element wetted.
For this filter, these integrity test standards have been fully correlated to the ASTM F838 bacteria Challenge test, in conformance with the applicable requirements of the FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (July 2019).
❖ Leak Test
Each filter element has been tested by TS Filter quality assurance based on the below Standards, then release: