About Quality
Ensuring high quality is a core commitment at Teclen®. Please see the measures and tests listed below, and scroll down for further information on the quality documents we supply.
In-house Quality Assurance
100 % visual inspection
We ensure that membrane and film are free of visual particles, nicks, pinholes or cuts. For other components, we check e.g. for scratches and dimensional accuracy.
Receiving inspection with FTIR spectrometer
We use Fourier-transform infrared spectroscopy to verify the chemical composition of incoming plastic goods.
Lot release tests
Seam strength test and seam tightness test for bag integrity.
Full traceability
All articles can be traced by means of lot numbers or serial numbers with the help of our ERP system.
References
Single-use products fulfill requirements of USP 788 and EP 2.9.19
USP 788 and EP 2.9.19 are pharmacopeial standards related to particulate matter in injections. They define limits for particulate matter and particulate contamination. Even after cutting, particles stay within the limits.
BSE/TSE safe
We use materials that are free from the risk of contamination with agents associated with bovinespongiform encephalopathy (BSE) and transmissible spongiform encephalopathies (TSE).
Compliance regarding food safety
Components comply with the regulations for materials and articles intended to come into contact with food according to (EC) No 1935/2004, (EU) No 10/2011 and (EC) No. 2023/2006.
Serial number and inspection certificate 3.1
For stainless steel semifinished goods, according to DIN EN 10204 3.1.
Tests by External Laboratories
Abrasion resistance of membrane
A modified Gelbo-flex test proved that the Lyoprotect® Membrane does not emit any particulate matter through appropriate usage.
Endotoxin test
Test for bacterial endotoxins using Limulus-Amoebocyte-Lysate (LAL test) with Lyoprotect® Membrane.
Sterile Barrier functionality
Microbial testing to prove the germ retention capacity with a Lyoprotect® single-use Membrane.
Quality Documents and Certificates
ISO 9001 certification
The Teclen Quality Management System is ISO 9001 certified by TÜV SÜD.
Quality documentation with CoI, CoC and CoA
Certificate of Inspection, Certificate of Conformity and Certificate of Analysis available.
Validation Guide
Validation Guide Basic on request, free of charge. Comprehensive Validation Guide Premium can be purchased. Currently available for Lyoprotect® Single-use Bags for Vials.
Made in Germany
Interested?
Send us a message.
Feel free to reach out with any questions.
We're here to assist you in finding the optimal solution for your specific needs.