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Sanockie Zakłady Przemysłu Gumowego STOMIL SANOK S.A. possess RW TÜV Essen and PCBC certificates which confirm compliance with the following standards: ISO 9001:2008, ISO/TS 16949: 2002 specification (including QS 9000 and VDA 6.1) and PN-EN ISO 14001:2005. The Company offers rubber products in line with the requirements of European Pharmacopeia, Type 1, chapter 3.2.9.
For all manufactured parts Quality Certificate issued by National Medicines Institute in Warsaw. Products’shelf life - 5 years.
Goods are produced in a selected facility of Stomil Sanok and are made of BIIR and CIIR based rubber compounds.
- unconventional, sulphur-free vulcanisation,
- LATEX FREE goods.
The perfect quality of rubber compounds is guaranteed by the use of certified materials permitted for pharmaceutical purposes from fixed, reputable suppliers.
A high level of purity in the goods, confirmed by the systematic monitoring of molecular purity, is guaranteed thanks to the effective washing in modern washing equipment operating automatic cycle, including washing in bacterially clean water from Reverse Osmosis station with detergent, silicone application, drying, cooling. Water for the last rinsing and silicone application meets the WFI (water for injection) requirements.
| | Dried products are packed inside laminar airflow cabins (Class 100, >0,5 m m in accordance with US Federal Standard 209E) into plastic, paper, polypropylene bags or TYVEK HDPE bags with steam sterilisation indicator.
A high level of hygiene during production, confirmed by the results of water, air, rooms, equipment and staff monitoring, as well as stable technology guarantee the microbiological purity of products identical to that of products after sterilisation. Goods are free from mould and bacteria.
ULTRA CLEAN products are to be sterilised at the customer's place – additional washing, drying and silicone application before sterilisation at the customer’s place are not recommended.
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