A deep dedication to manufacturing superior, high-quality products and superb client pleasure is our number one priority. The metering and dispensing techniques that Ivek generates present superb overall performance and reliability for the most demanding purposes.

The danger Investigation of the selected a few essential processes reveals that numerous dangers are inside the inexperienced limit, indicating which the RPN is below 34 (not introduced On this analyze); hence, there isn't any actions or Command measures required.

By adhering to stringent hygiene requirements, these machines safeguard merchandise integrity and make certain that medications are Risk-free for use.

From early-phase progress by professional manufacturing, Renaissance presents the abilities and regulatory history for making us an ideal companion on your sterile injectable and preservative-cost-free nasal spray systems.  To learn more be sure to stop by  

Methadone Dispensing IVEK features two methadone dispense programs: the Digispense DS1000 and the MethaSpense. These systems provide a very low squander, high precision that's fully supported globally. By far the most reliable controlled compound-dispensing programs that you can buy.

BevSource can help you locate the ideal facility and put a system with each other to your money expenditure.

Staff must be remarkably experienced, correctly skilled, and experienced. At last, specialised machines needs to be skilled and validated for every products manufactured. Also, the procedures are challenged consistently with media fills which fill the containers with a expansion selling media to make sure that the procedure proceeds to get on top of things.

Modest bottles and centrifuge tubes are perfect for sample collection, and also the integral tubing and protected silicone seal of Mycap® avoid contaminations and Phony positives.

Household owned & operated for fifty+ yrs– we put customer care and click here integrity at the center of all the things

Here the crew chose to reduce this unacceptable possibility by revising the applicable SOP and introducing the provision of conducting line clearance in the presence and acceptance in the QA inspector. This Management should be added into the Batch Manufacturing File (BMR). This control enhanced the detection level (small detection score) caused residual chance for being lowered to RPN equivalent to 48 (Yellow).

The more info quantity of containers useful for media fills needs to be sufficient to empower a sound evaluation. For little batches the amount of containers for media fills need to no less than equivalent dimensions of products batch.

The Biosealer® TC automatic sealing gadget presents a straightforward, flexible, and speedy Alternative for producing sterile disconnections across all biopharmaceutical manufacturing procedures.

IVEK techniques attribute ceramic favourable displacement pump heads coupled with a stepping motor drive that allows each and every metering and dispensing program to generally be highly specific, with flow rates from nanoliters and microliters to 9 liters/minute.

A “media fill” (occasionally known as a “method simulation”) could be the functionality of an aseptic manufacturing treatment utilizing a sterile microbiological development medium in place of the drug solution.