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 Sterilise Stoppers Item Part No.
Formulation West Art.
Quality Level Description
13mm Injection stopper with FluroTec™ barrier film 20mm Injection stopper with FluroTec™ barrier film 13mm Injection stopper with FluroTec™ barrier film 20mm Injection stopper with FluroTec™ barrier film 13mm Freeze Dry Lyo Stopper with FluroTec™ barrier film 20mm Freeze Dry Lyo Stopper with FluroTec™ barrier film
4023/50 Grey Bromobutyl 4023/50 Grey Bromobutyl 4023/50 Grey Bromobutyl 4023/50 Grey Bromobutyl 4023/50 Grey Bromobutyl
INJ13TB3WRSNP1
1358
NovaPure ® RS
INJ20TB3WRSNP
1343
NovaPure ® RS
Westar ® Select RS Westar ® Select RS
INJ13TB3WSRS
1358
INJ20TB3WSRS
1343
FD13TTB3WRS
Westar ® RS
1356
4023/50 Grey Bromobutyl
FD20TTB3WRS
Westar ® RS
1346
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-sterilise elastomer stoppers are supplied washed and packed in a sterilisable bag, ready for inhouse sterilisation. Please refer to pages 15 and 16 for our range of sterile, Ready-to-Use stoppers.
Specification
Westar®
Westar® Select
NovaPure™ (4023/50)
Particulate between 5-10um Not measured Particulate between 10-25um Not measured
None None
≤ 100 particles/10cm2 ≤ 60 particles/10cm2
≤ 13 particles/ 10cm2 ≤ 3.5 particles/ 10cm2 ≤ 0.9 particles/ 10cm2
≤ 13 particles/ 10cm2 ≤ 3.5 particles/ 10cm2 ≤ 0.5 particles/ 10cm2
Particulate between 25-50um
≤ 8.0 particles/10cm2
Particulate between 50-100um
≤ 1.0 particles/10cm2
Particulate > 100um
≤ 0.2 particles/10cm2
PCI
≤ 2.5 PCI
≤ 1.9 PCI
NA
Endotoxin Bioburden
≤ 1.0 EU/piece
≤ 1.0 EU/piece
≤1.0 EU/piece
≤ 5.00 CFU/100cm2 ≤ 5.00 CFU/100cm2 ≤ 5.00 CFU/100cm2
Click to see the full list
7
8
Made with FlippingBook Digital Proposal Creator