Operating Conditions

1. Product: Cytostatic injections.
2. Cleaning Media: SIP process (30 Min – Steam at 121 °C) and CIP (WFI-Water for Injection at 75 °C).
3. Size: 34/DN15; 50.5/DN15; 50.5/DN25; 50.5/DN40.
4. Temperature: up to 131 °C.
5. Pressure: 2 bar SIP and 3 bar CIP.

Customer

A manufacturer of cytostatic injections to treat oncological diseases.

Background

The customer struggled with a very short life time of the gaskets installed in their tri clamp connections. The gaskets showed high creep and cold-flow behavior and needed to be retightened after every single SIP (Sterilization In Place) cycle. The previously used gaskets were either made from virgin PTFE or envelope gaskets consisting of FKM core and outer virgin PTFE layer. The lifetime of these gaskets was approximately 2 weeks.

Challenges faced

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. Additionally the challenge was to ensure that the gaskets would perform well under the constant and difficult conditions presented by steam and high temperatures, so that the warranty period could be supported to meet customers’ expectations.

Solution and Benefits

Since the installation of GYLON BIO-PRO® PLUS the re-torqueing of connections is no longer necessary. The lifetime of the gaskets has increased significantly assuring a reliable performance at all times. After more than 100 cycles ran with GYLON BIO-PRO® PLUS the customer extended the gasket replacement period from 3 to 6 months. Even after 6 months in use the gaskets still looked very good so that the gasket replacement period can be extended in the future. Most importantly with GYLON BIO-PRO® PLUS the customer increased the plants productivity gaining 4 additional product-batches per month which they were losing in the past due to gasket replacement and re-torqueing efforts. GYLON BIO-PRO® PLUS with a very high density and low porosity easily passed the systems pressure/leak-testing cycle. During this test GYLON BIO-PRO® PLUS showed a steady result where previously used envelope gaskets showed a 10 times higher pressure drop.

For more product information

Download flyer: GYLON BIO-PRO® PLUS Case Study

Visit our European Webshop: GYLON BIO-PRO® PLUS

For more questions: Contact us

SCRI-IS Technologies Ltd, established in 2018 and ISO 9001 certified, specializes in asset reliability for biotech, pharmaceutical, and medical device manufacturers. Operating from their Callan Laboratory in Dublin, they offer expertise in asset management, reliability engineering, and data analytics. Recent independent testing at their facilities demonstrated the durability of Garlock’s GYLON BIO-PRO® and BIO-PRO® PLUS seals, successfully withstanding 1,000 SIP cycles—equivalent to 24 months of worst-case exposure.

For more information please visit: Pharma Production