INDUSTRY
Pharmaceutical
Water For Injection, electrolyte solutions, vitamin solutions, painkillers, herbal medicines and homeopathic preparations, sterile drugs and more.
CUSTOMER
The customer is specialized in high-quality contract manufacturing of 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.
OPERATING CONDITIONS
1. Media: Various pharmaceutical liquids
2. Temperature: 130 - 140 °C
3. Pressure: 8 bar
SOLUTION AND BENEFIT
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®.
文件分类:
案例研究
Product Type:
垫片
