Contact

MELAG Medizintechnik oHG
Geneststraße 6 -10
10829 Berlin
T +49 30 75 79 11-0
F +49 30 75 79 11-99
info@melag.de

Purchase

MELAG Sealing Devices for Practice and Clinic

Packing instruments quickly, safely and standard-compliant

Protect patients and practice staff with a safe workflow. Instrument packaging assumes an important place in the decontamination process to prevent the recontamination of the sterilized instruments.

Our high-performance MELAseal sealing devices perform a reliable and efficient packaging process in a practice and clinic context. The MELAseal series devices seal instruments in film packaging such as MELAfol after cleaning and disinfection and before sterilization in the autoclave.

Find out more about the advantages of the innovative MELAG sealing devices:

Info Icon

Heat sealing device:

International guidelines require that instruments are sterilized wrapped after cleaning and disinfection. Sealing individual instruments in sterilization film packages with a heat sealing device is the ideal measure for realizing sterile instrument storage. The seal seams must fulfil international standards. MELAG provides tips for safe packaging in sterilization film pouches:

The instrument length may only take up max. 75 % of the pouch and a minimum clearance of 3 cm must be maintained between the instrument and the seal seam.

The seal seam should exceed the minimum width of 6 mm.

The overhang behind the seal seam should amount to a standard of 1 cm. The overhang at the operneing side should amount to 3 cm, to enable easy opening of the pouches. Please always comply with the peel direction of the film packaging when opening.

 

MELAG rotary and bar sealers

Sealing devices tailored to the needs of your practice and clinic

The MELAseal Pro rotary sealer and the MELAseal 200 bar sealer fulfil the most-demanding requirements placed on reliability and efficiency. Both sealing devices produce standard-compliant and safe seal seams. The sealing devices are validatable and provide legally-compliant documentation of the process-relevant sealing parameters pressure, temperature and time. The difference between them lies in the number of instruments to be wrapped.

The MELAseal Pro rotary sealer is the ideal solution for practices and clinics with large numbers of instruments to be wrapped. The instruments are packaged ergonomically, quickly and safely through automatic feeding of the pouches in the shortest-possible time and without interruption. This ensures efficient operating procedures in the decontamination room. MELAseal Pro provides the additional advantage of a grooved seal seam 14 mm in width. The character of the seal seam guarantees maximum safety in the storage of sterilized instruments and especial ease-of-use when opening.

Sealing Devices MELAseal Series

 

The compact MELAseal 200 and MELAseal 100+ bar sealers are an affordable solution for medical and dental practices. The intuitive operation of the MELAseal series bar sealers produce reliable seal seams which comply with international standards. The integrated cutting knife and the roll dispenser make the MELAseal 200 and MELAseal 100+ the ideal sealing devices with low setup space requirements.

The energy-saving mode and standby function of the MELAseal 200 permit environmentally friendly and quick instrument sealing requiring only a few actions. The integrated LCD display and the USB documentation interfaces ensure complete control over the sealing procedure. The sealing log with all process-relevant parameters can be saved on the USB stick included in the scope of delivery.

Find out more about the packaging process with a sealing device in a medical and dental context in the following video. The complete video tutorial for the MELAseal 200 can be found on the MELAG Multimedia channel.

Packaging of instruments

Checking the seal seams in practice and clinic

Performing routine checks of the sealing device

A reliable seal seam can only be guaranteed if all sealing parameters (sealing temperature, sealing duration, sealing pressure) are fulfilled. Always adjust the sealing temperature to the specifications of the manufacturer of the sterilization film. With a pre-set sealing temperature of 180 degrees, our MELAseal sealing devices are already optimally-aligned to the transparent sterilization package MELAfol.

Regular tests verify the quality of the seal seam in practice and clinic. Profit from our aligned products for routine control of the sealing device. The video tutorial on the MELAG Multimedia channel summarizes the most important steps of the routine tests.

Routine Checks of sealing devices

 

Peel test
Perform and check a test seal seam once a day before starting work by performing a visual and mechanical check. To perform the peel test, sterilize the sealed film packaging in an autoclave. After removing it from the steam sterilizer, pull apart the seal seams slowly in the peel direction. The visual check is performed to check that the film has completely released itself from the paper. No fraying of more than 10 mm is permitted when opening the film packaging.
Document the results of the peel test and all further routine checks in a verifiable fashion. We provide a MELAG template checklist for this purpose.

Seal check
The weekly seal check of the seal seam can be performed with the MELAG Seal Check or MELAink test. MELAG Seal Check is a secure and efficient method with which to verify the seal seam. The contrast on the print sample permits the practice team to determine quickly and easily whether the film layer has fused with the paper side correctly. The seal check is inserted in the sterilization pouch and is successful if the complete seal seam contains even discolouration and sharp contours.
Find out more about the MELAG seal check.

Ink test
MELAink Test enables even better recognition of possible irregularities in the seal seam. The ink test is placed in a transparent sterilization package and sealed. Then the ink is pressed out of the test bag in the direction of the seal seams. The spread of the ink tests all four sides of the packaging, revealing irregularities, flaws or channels in the seal seams.
Find out more about MELAink Test.

Test for seal seam stability
The seal seam stability test is used to perform an annual check of the seal seam for tensile strength (tear-resistance) and validation of the packaging process using MELAG sealing devices. The seal seam stability test is a standardized test procedure for the performance qualification of your sealing device in accordance with international standards. The test is performed with a high-tech electronic test machine for guaranteed valid results. Download the application form for a MELAG seal seam stability test. The form depicts all the necessary steps for performing the seal seam stability test.
Find out more about the MELAG seal seam stability test.

Frequently asked questions

What are the advantages of a validatable sealing device?

Sealing devices enable the contamination-free storage of sterilized instruments until they are needed for the patient treatment. We provide routine tests such as the “seal seam stability test” or MELAink test to check the reliability and safety of the packaging seal seam. These tests should be performed at intervals established by regional authorities.

The hospital sector has long used sealing devices which perform an automatic check during the sealing procedure, documenting the three process parameters temperature, contact pressure and sealing time. The use of such validatable sealing devices in practice-based medicine is currently not mandatory in many countries, but often recommended.

Nevertheless, practices and clinics considering a new purchase should consider to choose a validatable sealing device, guaranteeing reproducible safety through continual monitoring and documentation of all the process parameters.

The MELAG sealing devices MELAseal Pro and MELAseal 200 are fitted with a process-parameter monitoring system as prescribed by international standards. Sealing logs are issued via the documentation interfaces.

Is a sealing device a medical device?

The requirements placed on a medical device are set out in the directive 93/42/EEC. In accordance with article 1 of the directive, a product is a medical device if section 2 of 93/42/EEC is applicable.

Neither section 2a, which describes products which are applied in or on the human body, nor section 2b (medical devices accessories) contains a description of the sealing device and its application. Appendix IX of the classification criteria does not provide a definition of a sealing device as a medical device.

As such, sealing devices are not classed as a medical device. Nevertheless, in developing and producing its sealing devices, MELAG orients itself around the requirements of directive 93/42/EEC. MELAG sealing devices thus comply with the constitutive requirements placed on a medical device.

How long may wrapped instruments be stored after sterilization?

The transport, commissioning and storage of sterile medical devices including the requisite packaging and marking are regulated by international standards. Loss of sterility is dependent less on the length of the storage time as from external influences during storage, transport and application. It is not possible to establish a storage duration for practice and clinic use.

The recommendation pertaining to the storage duration of medical devices is: paper and transparent packaging or another equivalent packaging can be stored in protected storage (in drawers, cupboard etc.) for six months. The storage duration of the instruments may not exceed the individually specified expiry date.

Packaging systems (combination of a sterile barrier system and protective packaging) can be stored for 5 years, as far as the manufacturer has not determined an alternative expiry date.

Unwrapped instruments should be used within 24 and 48 hours. Please always consider your national requirements.

The rooms used for storing medical devices should be dry, dark, cool and easy to clean. They must not be accessible to everyday activity. We recommend protected storage of the instruments in rooms and cupboards which comply with the requirements of international standards.

MELAfol is a transparent sterilization packaging (available as a roll or various size bags) perfectly adapted to MELAG sealing devices and complying with international standards. MELAfol is tear-free, sealed against germs and easy to open. Find out more about our MELAfol products for safe instrument storage after sterilization and approval.

OMFS clinic GesichtsPunkt
Mainz
DE
In MELAG, we have found a strong and reliable partner to help implement the highest hygiene standards, providing the best protection for patients and staff alike.
Trident Dental Clinic, Dr. Florin Lazarescu
Bucharest
RO
The MELAG system: the best hygiene workflows following European standards and regulations for safe and efficient instrument re-processing.
Esthetic surgery Dr. med. Daniel Talanow
Essen
DE
We attach great importance to patient safety - that is why we use MELAG products for the reprocessing of our instruments. Furthermore our Premium-Class steam sterilizer impresses with fastest cycle times.
This site uses cookies. By continuing to visit this site, you agree to our use of cookies. Learn more
x