Pharma Production
GYLON BIO-PRO® & GYLON BIO-PRO® PLUS
Increasing Productivity in Pharmaceutical Production
Higher productivity at lower cost
GYLON BIO-PRO® & GYLON BIO PRO® PLUS
In pharmaceutical manufacturing, soft part seal replacement can account for up to 50% of production down time.
Where there is a deficiency in the ability of elastomer seals to survive in the production environment, due to reasons such as chemical or
thermal breakdown, changing to a higher performing material leads to longer production campaigns and less downtime. This results in higher
productivity at lower cost.
GYLON BIO-PRO® and GYLON BIO-PRO® PLUS tri-clamp seals (made from high performance restructured PTFE) have a proven history of
excellent performance in pharmaceutical production.
GYLON BIO-PRO®
GYLON BIO-PRO® PLUS
Recent independent testing, at the leading facilities of SCRI-IS Technologies, has shown GYLON BIO-PRO® and GYLON BIO-PRO® PLUS
to successfully undergo 1,000 SIP cycles, simulating 24 months of worst-case SIP exposure.
The testing supports the use of GYLON BIO-PRO® and GYLON BIO-PRO® PLUS to give the benefits of:
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Increased production hours
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Savings in labour hours and cost
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Reduced waste disposal amounts and cost
SCRI-IS Technologies Ltd is a company that specializes in asset reliability for biotechnology,pharmaceutical, and medical device manufacturers. They offer services in asset management, reliability engineering, and advanced data analytics, operating from their Callan Laboratory in Dublin. Established in 2018, they are ISO 9001 certified and focus on maintaining operational continuity and compliance with industry standards.
Performance Evaluation
SCRI-IS evaluated the performance of Garlock’s GYLON BIO-PRO® and GYLON BIO-PRO® PLUS tri-clamp seals under 1,000 SIP cycles to simulate worst case SIP exposure equivalent to a 24 month period.
Test Set up
The test setup consisted of 3 x 1”, 3 x 1.5”, and 3 x 2” of the following
Garlock seals:
• GYLON BIO-PRO®
• GYLON BIO-PRO® PLUS
Test Conditions
The test conditions were continuously monitored throughout the process. During the SIP cycles, the average temperature was maintained at 132°C, while the system was cooled to 16°C during the water flush phase. The graph below illustrates the temperature profile over two complete cycles. After every 250 cycles, a 3 bar pressure test, held for 15 minutes, was conducted to validate the seal peformance.
Test Results: Submersion / Pressure hold test
The table displays the pass or fail verdict of the submersion / pressure hold test for each gasket at 0, 250, 500, 750 and 1000 cycles.
Conclusion
Both seal types demonstrated strong performance in terms of leak prevention, low retorque needs, minimal intrusion, and material integrity over 1,000 SIP cycles. They are well-suited for demanding biopharma applications, meeting high standards for cleanability, durability, and ASME BPE compliance.
GYLON BIO-PRO® PLUS: Cleanability Test
Test Set up
Test procedure according to EHEDG guideline 2:
• Contamination media (spore suspension and fermented milk)
• Contamination of pipe connection
• Drying of pipe connection
• Cleaning of pipe connection
• Verification of residual microorganisms (rinse water, gasket and reference)
Test Conditions
• Detection of residual contamination is carried out.
• Seals must be checked for antibacterial properties prior to testing.
• Relevant parts/surfaces are covered with growth medium.
• Covered seals are incubated at 58°C for 24 hours.
• Spores of the test strain produce well-defined color reactions in the growth medium.
Test Results
The presence of acid-forming micro-organisms causes a color change in the nutrient medium from violet to yellow due to the pH indicator Bromocresol purple.
GYLON BIO-PRO® PLUS
Showed repeatedly excellent cleaning results.
Surface Quality
GYLON BIO-PRO® PLUS with a smooth, low energy surface gives the best cleanability of tri-clamp seals.
GYLON BIO-PRO® / GYLON BIO PRO® PLUS
Applications & Benefits
Applications
| » Vaccines » Animal Vaccines » Bio-Pharmaceuticals » Oncology » APIs » Powders » Gel Caps » Water for Injection » Hydrofluoroalkanes (HFA) » Utilities, Autoclaves, etc |
Benefits
| » Longer time between seal change outs » More batches per month » No re-torqueing » Less bio-burden » Easier cleaning |
Summary
GYLON BIO-PRO® and GYLON BIO-PRO® PLUS are designed to improve productivity and reduce costs in pharmaceutical manufacturing.
These seals, made from high performance re-structured PTFE, address common issues with traditional elastomer seals, such as chemical and
thermal degradation, which often lead to production downtime.
Independent testing by SCRI-IS Technologies confirmed that both seal types can endure 1,000 sterilization-in-place (SIP) cycles, simulating
two years of harsh operational conditions. The tests demonstrated their durability, leak resistance, and minimal need for re-torqueing, making
them ideal for demanding biopharmaceutical environments.
GYLON BIO-PRO® PLUS also excelled in cleanability tests based on EHEDG guidelines, showing minimal microbial contamination and outperforming
conventional materials.
These seals are suitable for a wide range of pharmaceutical applications, including vaccines, oncology, APIs, and water for injection. They offer
benefits such as longer service life, fewer seal replacements, reduced contamination risk, and compatibility with all CIP and SIP cleaning
processes. Manufactured in Germany, they comply with major international standards including FDA, USP, and EC regulations.
GYLON BIO-PRO® / GYLON BIO-PRO® PLUS
Issues with conventional seals
Elastomers at their limits – 20 min CIP and SIP Cycle
Before…
.
After…
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Elastomer seals, such as EPDM, FKM, nitrile, and silicone, show degradation under the chemical and thermal processing of CIP (Clean In Place) and SIP (Sterilisation In Place). The acidic and alkali cleaners used in CIP cause elastomer breakdown that reduces service life. The thermal cycling of SIP causes elastomer breakdown and weight loss that reduces service life, and can potentially cause seal material contamination of the batch.
GYLON BIO-PRO® – Style 3504
Quality PTFE seals for the pharmaceutical industry
Main Segments
|
» Pharmaceutical » Food |
1) Depending on product and application details.
2) See Garlock resistance table.
Certificates/Declarations1)
| » FDA 21 CFR177.1550 » EC1935/2004 incl. EC10/2011 » USP Class VI <87>, <88> » USP <31>, <281>, <661> » Phthalate free » Silicone free » ADI free (EMEA 410/01)» Hydrocheck » BAM tested
|
Key Benefits
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» No intrusion/recession » High pressure & vacuum duties
|
Features
|
» Temperature: -268 °C to +260 °C » Filler: Aluminosilicate microspheres |
GYLON BIO PRO® PLUS – Style 3522
Quality PTFE seals for the pharmaceutical industry
Main Segments
| » Pharmaceutical » Food » Dairy – Lactose |
1) Depending on product and application details.
2) See Garlock resistance table.
Certificates/Declarations1)
| » FDA 21 CFR177.1550 » EC1935/2004 incl. EC10/2011 » USP Class VI <87>, <88> » USP <31>,<281>,<661> » Phthalate free » Silicone free » ADI free (EMEA 410/01) » TA – Luft incl. blow-out proof |
Key Benefits
|
» No intrusion/recession » 3-A Certified / Smooth surface (20-27) |
Features
|
» Temperature: -268 °C to +260 °C » 100% pure PTFE (No filler) |
Garlock GmbH
Falkenweg 1
41468 Neuss
Germany
+49 2131 349-0
garlockgmbh @ garlock.com
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