Telstar has released a new single-vessel good manufacturing practice (GMP) production freeze-dryer that is optimised...
Telstar has developed two high containment barrier systems for the Korean Komipharm Pharmaceutical, one of the largest producers of products from anti-cancer drugs in human oral dosage form to veterinary medicines in Asia.
The systems, one for API Sampling and the other for QC Sample Handling will be used in Komipharm’s new facility, built in the South Korean city of Cheongwon, Chungcheongbuk-do.
The purpose of the systems is to provide a high level of containment to protect operators during the manufacturing process using APIs (active pharmaceutical ingredients). In addition, the systems will be used in research in the biotechnology field aimed to develop vaccines by genetic technology.
Specifically designed for handling hazardous products, these containment systems run at negative pressure to the surrounding room providing operator protection during the manual product handling process and environmental protection for the product by virtue of the standard ISO 7 classification inside the Isolator.
This project has been carried out by the Technology Centre for Barrier Isolation Systems of Telstar, located in Dewsbury (UK).
For handling APIs containing raw arsenic or sodium arsenite
The two containment barrier systems developed by Telstar have been specially designed to handle APIs during pharmaceutical manufacturing and analytical testing of product containing raw arsenic. One of the Isolator systems is for API Sampling and the other for QC Sample Handling.
Both systems are based around the Telstar standard containment range to optimise cost efficiency, thus minimising design and assembly hours. Because of the standard design, the routine maintenance and every day running procedures are simplified and more cost efficient. Additionally, many of the featured parts are common, versatile and inter-changeable, which enables the client to avoid the over stocking of spares.
The development of the isolator design took into account aesthetics, ease of cleaning and general maintenance together with operator safety / efficiency. Integration of internal equipment is made possible via simple glands and tri-clamp connections. The forethought of including a spare port provides provision for future add-on services and can also be used for DOP testing of filters during annual service.
The API Sampling Isolator includes single sided operator access to the main working chamber with mobile frame and onboard main control panel. Seimens PLC/HMI, materials transfer chamber for continuous batch processing, an integrated weigh system, integral Telstar glove tester, safe change HEPA filtration, contained transfer port, vacuum system and temperature/RH monitoring, are specifically attributed to this process Isolator.
The addition of double sided access within its main working chamber, graphic data management for critical data storage via a modbus link, sockets to power a density tester, friability tester, hardness tester, sieve shaker, moisture detection and PH meter, completes the main characteristics specifically attributed to the QC Sample Handling Isolator.
The barrier containment system supplied to Komipharm stands out by its simplicity regarding the base design and control system, coupled with optional accessory enhancement to offer flexibility and adaptation if required in the future. Ergonomically trialled base designs were employed ensuring suitability of the final design to the required operations. Whilst providing cost savings this approach ensures that a high containment solution with operator comfort of equal priority is achieved.
Relationship is the key to success
A close working relationship was key in surmounting differences with the client in regards to both time zones and culture. Regular communication and face to face meetings together with willingness to adapt: revising the project scope and accommodating new requirements were paramount to the success of the project. Establishing this close working relationship resulted in seamless incorporation of project changes and ensured any issues or concerns were quickly resolved without determent to the budget or equipment delivery.
This Project has culminated in Telstar expanding its market base, of containment equipment using barrier containment technology into South Korea. Face to face meetings with Telstar was crucial in understanding our initial requirements together with special attention to particular details paramount in arriving at a fixed project scope, according to Kyung Seok, Kong, General Manager at Komipharm’s new facility in Cheongwon, Chungcheongbuk-do.
Telstar, part of the azbil Group, is an international leader in the development of high-technology solutions for the pharmaceutical and biotechnology industries. Acknowledged as the only company able to develop and provide integrated process systems for the biopharmaceutical industry with in-house sterilisation, freeze-drying, containment and clean air technologies, Telstar invests 3% of its turnover in research, development and innovation of its technologies and equipment
Komipharm Pharmaceuticals Co Ltd is a top leading company founded in 1972, producing a wide range of medicines (biological and pharmaceuticals), natural extract food additives and bio-fertilisers.
The purpose of the innovative inline vial management device developed by Telstar is to reject,...
Telstar has announced a new vacuum nucleation induction method in the freeze-drying process that is...
Pharmaceutical company Orion entrusted Telstar as a specialised partner in containment technology to supply various...