Our range of Medical Sealers are built to the high standards required in the healthcare & pharmaceutical sectors.
As one of the most fundamental parts of our life healthcare is receiving a unprecedented level of investment both from individuals and organizations.
During the past several years industry standards have been developed in the sector to standardize best practice and technique.
The global standard for sterile packaging primarily focuses around EN 868. Here all packaging systems and materials must conform with the standards set it section 1.
Part 2 to 10 focuses on testing procedures for the various packaging materials used.
Preceding this the ISO 11607 has been used an international standard for a number of years. Titled ‘packaging for end-sterilized medical products’ it was combined in 2002 with EN868-1. This has led to joint revision of ISO 11607 both part 1 & 2.
Part 1 of the revised standard is about requirements and test procedures for packaging materials. Wheres part 2 focuses on the Validation requirements and packaging processes.
This new standard states that all packaging processes must be validatable.
Also that validation is required to be a replicatable process.
For the sealing of sterile bags and packaging our range of Audion and HAWO sealers are easily validatable and will produce optimal seals every time you seal a package.
These medical sealers have built in parameter controls which will monitor acceptable parameters and block the machines operation when they are outside of these.
We offer calibrations services from an accredited laboratory to ensure the sealers are accurate.
Our validatable heat sealers are market leading and a important tool helping your organization to meet its regulatory obligations.
Read our Which Heat Sealer guide or get in touch for more information on medical pouch sealers and possible modifications.
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