Isolator

Nowadays, a large number of drugs contain active pharmaceutical ingredients (APIs) and highly active pharmaceutical ingredients (HPAPIs). In the process of drug preparation, operators must be strictly protected. Staff and the environment can be safeguarded by using isolation and high containment technology, as well as the clean system, to deal with APIs securely and efficiently.

Based on extensive practical experience with high-containment products and successful case experience in OEB5 drug production and R&D application, including batching, mixing, granulation, tablet pressing, coating, cleaning, isolation, etc., Chanse has designed a high-performance isolator that features crafted design and precision manufacturing, achieving containment level as low as the nanogram level.

The isolation barrier between the operators and the toxic substances (isolator shell with glove ports) protects both the operators and the environment when dealing with toxic drugs. Furthermore, the air supply and exhaust high-efficiency filtration system will generate constant negative pressure in the isolator's working area, and the closed condition and negative pressure environment will improve the safety level of operators.

Ergonomic isolation operating system, MOCK UP test

Meet the production requirements of OEB5 toxic drugs, SMEPAC test

The design of the system meets the requirements of GMP and Pharmacopoeia 2015, and the control system meets the requirements of 21 CFR Part 11

All safety-related functions are monitored by the system.

Products and materials are transported through the transmission system (RTP, α β valve, continuous bag and air lock).

The international advanced Ezi dock valve helps to realize the delivery of OEB5 drugs

The isolator is equipped with PUSH-PUSH and BIBO filters. The filter element can be replaced without pollution.

Leak rate: 0.25% vol/h.

Automatic leak test can be performed, and the report can be recorded and printed.

The work area can be cleaned manually with a spray gun. The spray head is optional.

The isolator is manufactured from fully-welded stainless steel(SS304L and SS316L) with rounded shell, and the bottom plate is inclined for cleaning.

The fan regulates the pressure by frequency control.

The system integrates instruments to collect operation parameters.

Protection measures can be added as required.

 

Details