How to avoid contamination: Teclen GmbH solution

How to avoid contamination: Teclen GmbH solution

January 16, 2019

As all freeze dryer users would know, filling of vials that are to be lyophilized has some problems that are somewhat unique. The stopper is placed on top of the vial and is ultimately seated in the lyophilizer. As a result the contents of the vial are subject to contamination until they are actually sealed.

 

In the FDA Inspection guide (Lyophilization of Parenteral 7/93) it is highlighted that “in the transport of vials to the lyophilizer, since they are not sealed, there is concern for the potential contamination”.

A suitable container system must be chosen for the product. The most common product containers are flasks, vials and trays. If possible, it is advisable to pick a container that keeps the maximum thickness of the product to less than ¾” (or 2 cm).

 

These containers are subject to the following matters:

  • Product loss: fluffy dry powder flies out during (or after) the freeze-drying cycle

  • Contamination: dry powder contaminates the freeze dryer and endangers operators

  • Cleaning and cleaning validation

 

Teclen GmbH has made its mission to help customers reducing these tedious issues. 

The company was founded in August 2016 by Rolf Lenhardt and it develops, manufactures and sells products for the pharmaceutical aseptic lyophilization industry.

 

Meet the Team

Rolf Lenhardt is a chemical-engineer with a strong technical background. He worked for many years for W.L. Gore & Associates Inc., mainly related to the chemical and pharmaceutical industry. He founded and shaped the company following his principles of innovation and excellent practice. 

 

Anja Busch joined Rolf in 2016 to support the growth and take responsibility in the international expansion of the company. Always in close contact with Teclen customers and suppliers, she has proven the potential and the quality of the brand Lyoprotect®.

 

Lyoprotect®

Lyoprotect® is Teclen registered mark, under its name the brand has developed different products to easy handle the lyo containers and eliminate contamination.

 

Lyoprotect® Bag: single use bags to contain trays or frames

 

 

Lyoprotect® Tray: expanded PTFE membrane on top of the tray that protects both product and operator

 

 

Lyoprotect® Threaded Cup: designed for APIs the cup is available in Aluminum and Stainless steel

 

 

LyophilizationWorld is proud to vouch for Teclen’s integrity and innovation spirit.

 

Make sure to contact Anja and discover more!

 

 

 

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