SEALING SOLUTIONS FOR PHARMACEUTICAL & MEDICAL APPLICATIONS
Knowledge, Challenges and Solutions
CIP and SIP technologies in the pharmaceutical industry – the cleanability of seals is a noteworthy factor in cases of failure.
CIP and SIP cleaning processes date back to the 1950s and were originally used in the food and dairy industries…
As a global supplier it was vital for the customer to ensure that all of their construction materials met the full suite of compliance standards, including FDA and EC1935.
The customer wanted to extend the lifetime of the sealing solutions of the plant. The requirements were conformity to FDA, EC1935 and USP.
The customer had high demands and decided to have their new progressive cavity pump tested and certified according to EHEDG guidelines Doc. 8 and Doc. 2
GYLON BIO-ECO® PLUS from Garlock has passed all testing within the official EHEDG certification process making sure that the customer was able to move forward in receiving the EHEDG certification for their new hygienic pump model.
The aseptic production process for cytostatic injectables underlies strict rules concerning the systems hygienic design.
As well as ensuring that the sealing solution should solve the leakage problem, it was also required, that the sealing material should be transparent to microwaves, chemical resistant to process acids and enough elastic to keep the sealing.
Compliance to industry standards was critical, as was the need for accurate documentation. Finally, due to significant plant expansion, the need for excellent customer service and very short lead times was essential.
The manufacturer was searching for a sealing which is free of “dead areas” and low wear as well. High demands placed on hygienic connections.
The need of flexibility and a competitive production cost often is in contrast with the reliability and efficiency of mixers sealing systems.
GYLON® offers a good possibility to use the advantages of PTFE, but due to its production process to eliminate the typical disadvantages – and even to improve the material. GYLON® is a modified and restructured PTFE.
GYLON BIO-PRO® PLUS: Cleanability Test
In order to assess the cleanability of the gaskets after the simulated cleaning procedure according to EHEDG guideline 2, they were tested for residual microorganisms.
GYLON BIO-PRO® PLUS: Intrusion Test
The gaskets were installed with the Tri-Clamp connections and the clamps screwed to the respective torques (PTFE gaskets with 5 Nm and elastomer gaskets with 3 Nm).
Certificates and Declarations
In order to meet the requirements of your special applications, we have subjected our materials to special tests.
Our experts are application engineers as well as sales engineers. All are highly trained and can discuss and debate the requirements of your applications with you professionally and expertly and advise you on the way to the best fitting sealing solution.
Solutions for Pharma & Medical Applications
Here is a brief overview of solutions for pharmaceutical and medical applications. Consultation with our experts will always be beneficial when dealing with a more complicated application.
GYLON BIO-LINE® / GYLON BIO-LINE® PLUS – for pharma industry
PS-SEAL® – PTFE based high performance seal
GYLON® – High performance PTFE gasketing
We answer your questions!
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