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
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