Adelphi Healthcare Packaging USA CMO brochure

Stoppers for Pharmaceuticals Stoppers provide a secure seal that protects medication from contamination and preserves sterility. Made from a synthetic and dry natural rubber-free butyl elastomer, high-quality stoppers ensure safety and effectiveness. Their reliability is crucial for regulatory compliance and for maintaining the integrity of injectable drugs and vaccines.

Ready to Sterilize Stoppers Item Part No.

Formulation West Art.

Quality Level Description

4432/50 Grey Chlorobutyl 4432/50 Grey Chlorobutyl 4432/50 Grey Chlorobutyl 4432/50 Grey Chlorobutyl 4432/50 Grey Chlorobutyl 4432/50 Grey Chlorobutyl

INJ13-4432WRS

Westar ® RS

13mm Injection stopper

V-35

INJ20-4432WRS

Westar ® RS

20mm Injection stopper

S-127

13mm FluroTec™ Injection stopper 20mm FluroTec™ Injection stopper

INJ13T3-4432WRS

Westar ® RS

S2-F541

INJ20T3-4432WRS

Westar ® RS

S10-F451

13mm FluroTec™ Freeze Dry Lyo Stopper 20mm FluroTec™ Freeze Dry Lyo Stopper

FD13T3-4432WRS

V2-F451W Westar ® RS

FD20T3-4432WRS

V10-F597W Westar ® RS

Stoppers West elastomer stoppers help preserve drug quality and safety by providing an airtight seal against the neck of the injection vial. They are available in injection and freeze dry lyo designs to suit your process, and can be offered with a selection of premium features, such as FluroTec™ barrier film which significantly reduces the risk of interaction between the drug and the closure. Ready-to-sterilize elastomer stoppers are supplied washed and packed in a sterilizable bag, ready for inhouse sterilization. Please refer to pages 15 and 16 for our range of sterile, Ready-to-Use stoppers.

Specification

Westar®

Particulate between 5-10um

Not measured

Particulate between 10-25um

Not measured

Particulate between 25-50um ≤ 13 particles/ 10cm2 Particulate between 50-100um ≤ 3.5 particles/ 10cm2 Particulate > 100um ≤ 0.9 particles/ 10cm2 PCI ≤ 2.5 PCI Endotoxin ≤ 1.0 EU/piece Bioburden ≤ 5.00 CFU/100cm2

7

8

Made with FlippingBook Digital Proposal Creator