van der stahl

Vacutek is available in two versions, manual (7914.340) and motorized (7914.345), which differ only in the automatism that closes the jaws to start the air extraction cycle and subsequent welding of the barrier bags. The 7914.345 motorized Vacutek is furnished with a foot-pedal. Furthermore, having the 7808.340 model it is always possible to switch to the 7914.345 motorized model using the special 7914.341 upgrade kit. The advantages of Vacutek are: 1) it is possible to use both flat and textured bags 2) No danger for the operator with the motorized version Unlike other motorized vacuum machines, the pressure exerted by the jaws moving is not sufficient to cause damage to the hands. 3) Wide jaw opening Excellent visibility when the mouth is open (the jaws open up to 45° in both Vacutek versions. This allows the operator to insert the bag quickly and accurately. Vacuum heat sealer with external aspiration 4) Little effort to start the cycle Both Vacutek models can start the suction cyc...

Packaging Distribution Prior to receiving regulatory approvals, the SBS must prove that it's capable of withstanding the expected transit life cycle. Testing intensity is decided to support the precise device and system. Final testing after simulation proves the strength and integrity of the SBS. Aging Studies Aging studies must be completed before receiving regulatory approvals to prove the SBS remains intact at the top of the labeled time period. Medical package testing must verify package strength and integrity after the specified time point(s). Accelerated aging is often completed for regulatory submission, but real-time aging samples must run in parallel. Types of Package Testing Package Integrity Testing Package Integrity Testing is vital in determining sterility and therefore the time period of a medical device or product. This is done by documenting that the SBS system has no detectable path through, channels or punctures which will allow the introduction of microbes into ...

Material Considerations Consider the approximate size and weight of the Medical Device Packaging Equipment , the sterilization method(s), and thus the proposed quantity of sterile barriers (single barrier or double barrier) when designing the SBS. Determining your requirements early will help reduce lead times typically associated with packaging design and may leave early feasibility studies. Equipment Qualifications IQ (Installation Qualification) This testing provides documented evidence that the utilities, safety features, and ancillary systems utilized within the function of the equipment meet the user’s specified requirements. OQ (Operation Qualification) This testing provides documented evidence that the upper and lower limit sealing operating parameters of a touch of kit provide seals that meet predetermined acceptance criteria for a specific material combination. Engineering studies should be completed before the OQ to figure out these limits and acceptance criteria. PQ (Perfor...