AGT Automatic Glove Tester: Our solution to GMP Annex 1

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March 1st 2009 is the date for coming into operation of the Annex 1 of the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use.

The Annex 1 regards the Manufacture of Sterile Medicinal Products and details that the special requirements the manufacture of sterile products are subject to with the aim to minimize the risks of microbiological contamination, and of particulate and pyrogen contamination.

While much depends on the skill, training and attitudes of those involved, the document states that

“Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test”.

The Annex1 guidelines are divided into

• General guidelines
• Clean room and clean air device monitoring guidelines
• Isolator technology guidelines
• Blow/fill/seal technology guidelines
• Terminally sterilised products guidelines
• Aseptic preparation guidelines
• Personnel guidelines.

Paragraph 25 of the document is dedicated to Isolator technology and states that

“Monitoring should be carried out routinely and should include frequent leak testing of the isolator and glove/sleeve system”.

AGT Automatic Glove Tester
our Solution for frequent leak testing of the isolator and glove/sleeve system

Comecer has always paid much attention to safety and has several time tested products that ensure the safety of laboratory personnel and environment. One of these is the AGT Automatic Glove tester, a The AGT Automatic Glove Tester and Leak Tester has all the features that make testing a simple and complete operation.  It is used to test glove integrity in conformity with the pressure decay method ISO 14644-7 Annex E.5 (test in positive pressure).

All the product details are available at
www.comecer.com/isolation/agt-automatic-glove-tester/