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, relying on a diverse range of heat sealers, and other sealing machinery.
The global packaging standard for terminally sterilized medical devices 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 as 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 BS EN ISO 11607 both part 1 & 2 to form the new BS EN ISO 11607 package validation testing standards.
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 continuous band sealing of sterile bags and packaging our range of HAWO heat sealing machines are validatable and will produce optimal seals every time you seal a package. All our medical sealers have built in parameter controls which will monitor acceptable parameters and block the machines operation when they are outside of these.
The HM 850 DC-V and HM 950 DC-V NanoPak medical pouch heat sealer are suitable for projects where packaging must be sealed according to EN ISO 11607-1:2009, EN 868-4:2009 & EN 868-5:2009. These advanced machines are designed for the sealing of pouches and reels (SBS Sterile Barrier Systems) in hospitals (CSSD), medical or healthcare environment.
For vacuum bag sealing or air extraction/purging work see our HV range of both sealers and degassing chambers.
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.
For more information on our wide range of medical heat sealers, don’t hesitate to get in touch with our experienced team today!
Rotary Heat Sealer | Hawo HPL 500 D-V & 3000 DC-V£ 2,548.25 – £ 2,798.65 Exc. VAT Select options
HAWO HPL 300 & 500 BMS | Table Top Heat Sealer | Valdamark Direct£ 825.00 – £ 1,151.70 Exc. VAT Select options
HAWO®HPL ISZ 300, 450, 630mm | Hand Held Impulse Heat Sealer | Valdamark Direct£ 298.50 – £ 1,138.32 Exc. VAT Select options
HAWO hm 460 AS-V & hm 660 AS-V | Validatable Impulse Sealers | Valdamark DirectRead more
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Hawo® hv 321 K-V MediVac | Next Generation Vacuum Chamber SealerRead more
Hawo HV 460/660/800/1100/1300 AP2/4-V | Next Generation High Performance Impulse Vacuum Sealer | Clean Room Compatible | Air Purity Class 6 / ISO 14644-1Read more