Quality control and hygiene standards
The Medical Solutions Pharma Packaging Quality
It is our policy that all the products and services from us must comply with the highest standards and protocols, which in practice means always delivering the right quality, in the right quantity, at the right time. We achieve this through our employees′ professionalism and training, our quality control systems and by our on-going investments in the latest technologies. We also place strict demands on our suppliers regarding sustainability, quality, hygiene and secure deliveries.
Strictly hygienic production conditions
Our highly automated production of injection blow moulded, injection moulded and extrusion blow moulded plastic products conforms to strict hygiene requirements (ISO class 8 in general) to prevent product contamination. In the event of higher requirements, such as the manufacture of products for sterile use, we can manufacture products in ISO class 7 cleanrooms.
We employ Good Manufacturing Practice
When producing packaging for pharmaceuticals, ophthalmics and VMS (Vitamin and Mineral Supplements), we follow Good Manufacturing Practice (GMP). This includes full batch documentation whereby traceability of products and raw materials is part of our standard procedures. Batch documentation is retained for at least five years, and selected products are listed in a type III Drug Master File with the FDA. Unique products can also comply with the requirements of ISO 13485 and CE, UN, Kitemark and NF.
Rigorous in-line quality control
Packaging is checked in-line during the production process using various technologies, such as in-line camera inspection and leakage test systems that can check both containers and caps for deviations. With a computerised and automated system we are able to detect and eliminate practically all defects, for instance black spots and deviations in wall thickness. Other important parameters, such as opening force, axial strength and dimensions, are also checked continuously during production. Furthermore we arrange additional testing programmes, e.g. bio-burden testing and sample preparation for dose audit/dose mapping.
Standards guarantee that both the manufacture and the products fulfil the requirements that are placed on the company by the customers and society in general. Compliance with these requirements is controlled by means of regular audits by independent auditors from Intertek, SGS, BSI and, importantly, our customers.
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