Healthcare and Life Science applications

Seal CheckIT

Test system for the daily testing of sealing device and for Operational Qualification according to EN ISO 11607-2:2006 process Validation

Guidelines of the WFHSS are advising to test each medical heat sealer at the beginning of the day after the heat sealer has heated up. Based upon the initial test the heat sealer can be released for the day.

The Gandus Saldatrici Seal CheckIT is one way to comply to the ISO 11607 – 2 requirements for Operational Qualification (OQ) and daily testing of your Medical Heat sealers.

  • Is the sealing temperature defined and correct?
  • Are speed and force the most suitable for that kind of product?
  • Did the manufacturer indicate these parameters inside the specs?

How does it works?
Place in between the layers of medical pouches with the face up to the laminate side of the pouch. The combination is then heat-sealed.

By its unique printed pattern of the black area the inspection of the seal and the detection of minor or bigger problems are easily detected.

The following heat sealer problems can be displayed:

  • Sealing temperature too low
  • Sealing pressure too low
  • Interruptions in the seal

Compliance to standards
The Gandus Saldatrici Seal CheckIT is compliant to the following standard:
Procedure: ISO 11607 – 2
Materials: ISO 868 – 3