High Containment Isolator is used for protecting the operation environment during the highly toxic and highly active powder material transfer, filtering and drying, crushing, weighing and packaging process to avoid cross contamination during drug manufacturing and guarantee the operators’ occupational health.  PUSH-PUSH safe-change H14 HEPA filter is used for the inlet air and exhaust air of the isolator to provide OEB5 containment level for protection. There are multiple ways of material transfer: continuous liner, RTP drum, and high containment valve and drum.

The ChargePoint split butterfly valve (SBV or αβ Valve) agented by AUSTAR is the inventor of SBV technology and also the international leading brand for the product. 

• The technology meets OEB4 and OEB5 requirements for contained transfer of high toxic materials;

• The technology meets the B/C/D grade requirements for sterile transfer of powder materials and sterile components in clean area;

• ChargePoint provides several versions of products (i.e. manual type, semi-automatic, full automatic etc.) for clients’ selection according to their operating process;

• There are also different accessories available to accomplish WIP and SIP process requirement;

• The new interlocking structure ensures easy and simple operation;

• The unique seat design and high quality elastomer raw materials ensures repeated use for sterilization and to meet special needs for chemical corrosion resistance.

Rapid Transfer Port is a device used for material transfer between closed environment (i.e. the isolator or the cleaning rooms) and the external space. Strict closure of ALPHA door in the isolator wall and BETA door of the container can be guaranteed by applying the ALPHA-BETA technology. Only after docking and connection of the both parts, the doors can be opened for material transfer. This meets the requirements of OEB5 protection level. Sterile RTP meets the requirements of sterile protection and can realize SIP.

The RTP port manufactured by AUSTAR is based on the technology of Cape Europe Company of UK. AUSTAR RTP port possesses patented design and the 5 interlocking mechanisms fully meet the mechanical safety requirements. The new Alpha door handle is ergonomically designed and easier to handle when the operator wears gloves. With the lower torque, the high performance lip seal is more labor-saving when operated.

OEL Validation of the Pharmaceutical Equipment.

The OEL validation is formulated by AUSTAR’s consultant who is CIH (Certified Industrial Hygienist). The validation process is implemented by AUSTAR team with final test report signed and released by CIH, conforming to FDA requirements. The test scheme is jointly determined by CIH and EHS department of the client after in-depth discussion. The content of the report includes: test purpose, equipment description, test scheme design, record of implementation process, test data and conclusion, etc. with finally proof for whether the selection and design of equipment meet the containment requirements (OEL value).