Danish Quality

There are very high requirements for the product and manufacturing standard.

MedicoPack is certified according to ISO 9001, ISO 13485 & ISO 15378 and in addition we work in accordance with EU guidelines for good manufacturing practice and hygiene.

MedicoPack offer clean room production facilities. The clean room class 10,000 (C) is constructed according to EU Directive 91/412 EEC, inclusive of guidelines.

Quality System Certificate »

Certification – Design and manufacturing of containers and vials for medical use and mixing devices for infusion fluids »

Certification – Development, design, manufacture and distribution of bottles, vials and containers for pharmaceutical use »

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Specific testing on products are on-going:

Bacteriological Particle PhEur USP Extractable Endotoxin Light transmission test LIF test Microbiological test
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Medical Device Manuals are available on all standard products as well as DMF Registration.

The raw material and components are tested at external laboratories. Random samples of raw material granulate are tested according to Ph.Eur. §3.2.2.1. “containers for aqueous solutions for parental Infusion”. Extract of autoclaved containers is tested for pyrogens and abnormal toxicity according to Ph.Eur.

The rubber disc and alu-foil is subject to internal control.

Furthermore our production facilities are subject to unannounced external general hygiene control.