Active Pharmaceutical Ingredient Isolator - API Isolator

Jacomex designs and manufactures 100% custom-made pharmaceutical isolators perfectly adapted to the operations and processes to be carried out in the chamber, including pharmaceutical isolators for the development and production of Active Pharmaceutical Ingredients (APIs). The company has all the necessary assets to provide a reliable technical solution to the innovative projects of tomorrow’s pharmaceutical industry and research… and they are essential:

Longstanding experience in the nuclear field,
A multisectoral design office integrated within the company,
A developed range of high security systems for operators and the environment
A know-how in stainless steel boiler making for unequalled quality and finish,
A perfect understanding of the goals, risks and stakes during the URS (User Requirement Specification) study,
Its excellence in the mastery of sealing etc.

In a sector where environmental and operator safety is a priority, JACOMEX supplies pharmaceutical isolators for the development and production of Active Pharmaceutical Ingredients (APIs).

Active Pharmaceutical Ingredient Isolator - API Isolator

Environment and Operation of the Pharmaceutical Isolator

Designed to be installed in a clean room, in a controlled area, the API isolator operates as a stand-alone unit with a ventilation system that draws in ambient air passing through ULPA filters and a HEPA filtered exhaust collected on an extraction network.

The internal chamber is under vacuum (at a pressure lower than that of the clean room) with a continuous control of the parameters temperature – humidity rate – pressure – ventilation flow rate … directly displayed and configurable on a touch screen with integrated PLC. The API isolator is designed with opposite working sides in order to improve internal accessibility, ergonomics and working comfort when working with gloves.

Pharmaceutical Isolator Design, Cleanability, and Maintenance

API isolators are AISI 316L stainless steel monobloc welded boxes with all corners rounded, welds and surfaces polished with controlled roughness (Ra < 0.8µm), and external stainless steel fairings; all elements that guarantee perfect cleanability. In order to facilitate the maintenance of the API isolator, the mineral glass working faces on one side are secured lift-up panels giving total access to the inside of the insulator.

API Isolator System Safety

The main airlocks are fully automatic, equipped with safety interlocking to prevent tampering and autonomous filtration. The isolator is equipped with double ULPA – HEPA H14 filtration and differential pressure gauges to check the clogging rate of all filters. The isolator has a Bag-In-Bag-Out system for waste disposal and a flange for the safe transfer of active ingredients by bag or bottle. A JACOMEX valve ensures an automatic maintenance of the vacuum in the chamber as well as an air speed of 1m/sec, thereby avoiding any release of toxic substances towards the outside in case of accidental breakage of containment on a glove.

Certification and documentation: most of the components are made of AISI 316L stainless steel. However, the use of other materials is FDA – USDA compliant and BSE/TSE certification is provided. The isolator is subject to IQ-QO qualification and FAT-SAT testing.