Liquids Forms
Parenteral Use Stoppers
SANOK RUBBER is a Polish industrial group with 1,700 employees and presence in 7 countries.
From its plant in Sanok, Poland, its pharmaceutical division manufactures butyl stoppers for parenteral use in accordance with the most demanding quality requirements of the pharmaceutical industry.
| OPENING SYSTEM |
Infusion Stopper |
Serum Stopper | Lyiophilization Stopper |
|---|---|---|---|
| Available diameters | 28mm, 29mm, 32mm, 34mm | 13mm, 20mm | 13mm, 20mm |
| Stock | On demand |
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Ready to Sterilize (RTS) |
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| Sterile Validated (RSU) | In Development |
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In Development |
| DMF type III |
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| Euph |
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| FCC |
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| IR spectrum per batch | On demand | On demand | On demand |
| Endotoxin analysis | On demand | On demand | On demand |
| Cellular Toxicity Analysis | On demand | On demand | On demand |
CERTIFICATIONS AND QUALITY:
- ISO 9001:2008
- ISO/TS 16949:2009
- ISO 14001:2004
- OHSAS 18001:2007
PRODUCT QUALITY ACCORDING TO PH.EUR/USP
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Additional controls according to ISO 8871: Extractables and chemical-mechanical stability tests.
OUR SERVICE – ADAPTATION TO THE PARTICULARITIES OF OUR CLIENTS:
- Products in stock or exclusive productions with delivery within a maximum of 4 weeks.
- Flexible batches with very accessible minimum order quantities.
- Adaptation to special packaging and labelling conditions.
- IR spectra by batch (upon client request).
- Personalized CoA with detailed batch assessment report (upon client request).
- Experts in the development of new moulds and products: the ideal partner to start new projects.
OUR QUALITY:
- High purity and low particle load.
- Exhaustive microbiological monitoring (limit: 0.01 cfu/10 cm²).
- Endotoxin controls per batch (limit: 1 EU/pc).
- Visual and dimensional controls on 100% of the product during the process.
- Packaging in laminar flow cabinet class 100.
- Secondary packaging in Certified Cleanroom Class 10,000.
- Validation of irradiation available free of charge for the client.
Glass Transformation
Prefilled
Syringes
Aluminium
Caps
01 - 05
Liquid
Forms
03 - 05
Ophthalmics
04 - 05
Solids
05 - 05
