A deep dedication to manufacturing top-quality, excellent goods and remarkable purchaser satisfaction is our number one priority. The metering and dispensing systems that Ivek produces provide excellent efficiency and trustworthiness for the most demanding programs.

one. One particular contaminated unit should really end in an investigation, which include thought of repeat media fill;

Place force differentials must be monitored on an ongoing foundation. Partitions, flooring and surfaces must be subject matter to a pre-established program of cleaning and disinfection.

All aseptic manufacturing procedures are performed inside a cleanroom that need to meet many regulatory requirements to make sure the sterility and quality of drug merchandise. Generally, a cleanse area can be divided into two regions: the important location and supporting clean up areas.

During the pharmaceutical sector, quality risk administration is more and more starting to be a requirement. Numerous, if not all, regulatory organizations recognize QRM for a ingredient of the standard technique that permits the reduction, checking, and managing from the probability and/or effects of possibility.

To start utilizing the Biowelder® TC automated tube welder, an operator inserts the tube holders, the disposable blade and the TPE tubes and initiates the welding procedure by using the touch screen.

Filtered compressed air and granules of a plastic product here conforming to the predetermined specification and regarded being appropriate Along with the merchandise to become loaded (generally polyethylene, polypropylene or polyethylene/polypropylene co-polymers) are provided towards the equipment.

Modest bottles and centrifuge tubes are ideal for sample selection, plus the integral tubing and protected silicone seal of Mycap® prevent contaminations and Wrong positives.

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For products that can’t stand up to terminal sterilization, manufacturers hire aseptic manufacturing. The aseptic manufacturing course of action calls for the drug product and any excipients, the container, along with the stoppers to be independently sterilized in advance of becoming released into the cleanroom or sterile manufacturing core the place the ultimate product is made within a really managed atmosphere regularly monitored for air high-quality and likely microbial ingress.

Guide filter integrity exam shall not be made use of. Filter examination shall be performed employing equipment, and screening success really should be routinely saved and printed. No handbook recording of the result.

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Liquid Metering IVEK gives higher precision liquid dispensing methods capable of metering between 1uL/moment – six Liters/minute from only one Pump (nearly eighteen Liters/minute for twin ended pumps blended). Micro stepping allows for stream profiles which will get to sub-milliliter delivery around hrs.

A “media fill” (often referred to as a “procedure simulation”) will be the overall performance of the aseptic manufacturing method employing a sterile microbiological growth medium instead of the drug solution.