Production Technology of our RENOLIT SOLMED products
RENOLIT MEDICAL’s SOLMED products must be of the highest quality in terms of hygiene and cleanliness and have to meet the stringent requirements of the various Pharmacopoeias.
The quality assurance system of the main production sites has been certified according to ISO 13485. Where possible Good Manufacturing Practices are used and many precautions are taken to ensure a clean and compliant production environment:
- HEPA filtered air
- positive pressure
- specially validated clean room sections for critical products
- clean room clothing, hair and beard covers, special shoes
- insulated machine area
- restricted entry
- regular audits
The operators are regularly trained regarding Good Manufacturing Practices. The production equipment is custom made and specially designed to operate in a controlled environment.
All products are packed in double polyethylene bags before leaving the production clean room. In a special packaging area, the products are packaged according to customer specifications and shipped to the warehouse. The packaging is developed to minimize the risk of transport damage. Multi-roll carton boxes reduce the amount of packaging materials without compromising the packaging’s integrity. For long distance intercontinental shipments a specially developed packing system is used to protect the product and to optimize container loads.