Operating Conditions

1. Media: Various pharmaceutical liquids
2. Temperature: 130 – 140 °C
3. Pressure: 8 bar

Customer

The customer is specialized in high-quality contract manufacturingof sterile preparations in glass ampoules and glass vials in Germany. Their name represents a state-of-the-art production technology with more than 40 years of specific experience in the industry.

Background

The production range of the company includes the manufacture and filling of glass ampoules from 1 ml to 30 ml and glass vials from 5 ml to 500 ml. All preparations can be produced aseptically or sterilized after manufacturing and filling.

Challenges faced

The customer was looking for a solution for its distillation plant for the production of WFI as per Pharm Eur (European Pharmacopoeia) and USP out of fully deionised water. The distillation plants are economically operating and reliable plants for a capacity up to 50 l/h. The customer is able to construct these plants in various ranges of capacity, e.g. 3 – 8 column plants, electrically or steam heated. The customer wanted to extend the lifetime of the sealing solutions of the plant. The requirements were conformity to FDA, EC1935 and USP.

Solution and Benefits

In investigations and joint discussions with Garlock, the best solutions were found to be GYLON BIO-PRO® (Style 3504) according to DIN 11850 and DIN EN 10357 and GYLON BIO-ASEPT® (Style 3504) according to DIN 11864 and DIN 11853. Due to the superior properties of GYLON BIO-PRO® in its behaviour to load and temperature changes, the customer was able to extend the lifetime up to four times. GYLON BIO-PRO® also ensures conformity to FDA, EC1935 and USP. In addition the effectiveness of the Garlock solutions also convinced the OEM manufacturer to use GYLON BIO-LINE®.

For more product information

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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