Quality control isolator HPAPI QC

class IIIcontainmentfor highly potent active pharmaceutical ingredients

The Quality Control HPAPI isolator is designed to perform high containment for fine particle size products and operations. The isolator works at negative pressure (-100 Pa for airlocks and -150Pa for working chambers) to protect the operator: isolator chambers works under nitrogen blanketing. Highlights Communication laterally hinged door Oval glove flanges of 12” made of PP (Polypropylene) complete with gloves for materials handling Speedy Gloves for glove intergity testing Drainage sanitary tank bottom valve activated by footswitch and protected by cap with holes Working plane sloped to drain valve Oxygen analyzer Led Lights Predisposition connections for WFI, PW, compressed air, vacuum, nitrogen, power/data cables and other necessary utilities Integration of analytical scale and a touch-screen external display Integration of magnetic stirrer Integration of ultrasonic stirrer Integration of Coulometer with internal titration stand/base and external hardware Integration of titration unit T90 with 3 internal bases 3 external dosing units and external hardware The isolator system is fitted with a sanitary drain system WIP for the whole isolator system is included. The design is conform to cGMP standards and is designed and fabricated in accordance with pharmaceutical standards for primary and secondary manufacture. Interior surfaces are constructed with rounded corners providing smooth interior surfaces and crevice avoiding surfaces. The Quality Control HPAPI Isolator is composed of following modules: n.1 Airlocks for materials decontamination. n.1 Wet analysis process chamber with analytical scale and titration units.