Compliance consultation of EHS/cGMP in containment technology
With regard to isolation technology, AUSTAR, together with experienced experts from the US, EU and other countries, provides cGMP consultation for high potent, toxic and allergic drug production. For instance, co-production risk identification, cross-contamination and contamination control in production, protection to personnel, environment and product, development of cleaning procedure, analysis method develop and validation, product develop, technical transfer management, deactivation and treatment for high potent product.
AUSTAR improves the industrial EHS management by providing consultation and services of determining the PDE/ADE/OEB/OEL data and establishing documentation, evaluating of contact of active substance, containment performance, industrial hygiene, and management of Active Pharmaceutical Ingredient.
Design and review in containment technology
AUSTAR has profound experiences in design and design review, and accumulated project experiences through successful application cases of world scope, which ensures our capability of providing satisfactory services to the clients.
AUSTAR assists clients to control the high potent product contamination based on the containment/ isolation strategy and control measurement, and conducts system analysis to the material residual, cross contamination, mechanical/ pneumatic transfer during feasibility study, concept design, and implementation. The risk assessment method is applied to system analysis based on material characteristics, OEL, special sensitization, and process attribute; the system analysis includes containment equipment/ insurance, dedicated equipment, single use transport device, process containment system, HVAC system, clean room engineering, layout positioning, co-production, process of waste, and CIP/WIP. Through above activities, AUSTAR could provide the EHS, cGMP complied, high standard industrial design and review for the client.
IT, HVAC and clean room in containment technology
AUSTAR assists clients to monitor, control and management of personnel/ material/ waste flow by building up WMS/BMS/EMS/MES system. With the isolation equipment, control measurement and management procedural, production area of high potent, toxic product could be controlled and isolated to prevent the mix-up and cross contamination, further to support the implementation of contamination control and isolation strategy.
In the design and implement of HVAC system, with the scientific clean room and HVAC dividing, pressure differential configuration, the special design of sampling room, application of online environment monitoring and clean room execution quality control, it could control the pneumatic transfer risk, and support the implementation of contamination and isolation strategy.
AUSTAR has rich experience in design and installation of HVAC system and clean room project, and made targeted improvements and upgrades, for instance, the determination of recirculation/ direct exhaust airflow, position of recirculation of HEPA, optimization of airflow volume and pressure differential control, determining of clean room maintenance and material selection, and environment sanitation and sterilization.
AUSTAR HVAC and clean room system and installation comply with pharmaceutical containment related regulation requirements, and meet the requirements of energy effective.
Process containment system and test service in containment application
AUSTAR provides differentiated and systematic solution of process containment system, from individual stainless-steel rigid isolator, plastic flexible isolator, RTP valve, to process customized solution and meeting the process containment requirement of OEB4/5, API, OSD, sterile product (e.g. microsphere and antibody-drug conjugates dosage) for the lab scale and commercial production.
AUSTAR could provide the containment performance test protocol, reporting, service and the analysis method validation protocol and report for the high toxic and potent product cleaning validation, and the environment monitoring protocol and report for the high allergic product.
Having been trained in and certified by internationally recognized institutions, the testers of AUSTAR are able to prepare practical and reliable test plan according to clients' process site operation requirements and system features, select reasonable test spots, test tools, sampling methods, test methods and flows according to operating and exposed risks, and conduct the test strictly in accordance with the test plan.