Isolation Technology for the production environment
An introduction to Isolation technique
During the late 1970's, La Calhène, made the first isolator systems based on knowledge and experience gained in the nuclear industry. Since then, Isolation techniques has found many and varied applications in Pharmaceutical Manufacturing. The basic goal of Isolation Technology is to prevent cross-contamination. Like cleaning and sterilization, it is at the core of Getinge's Infection Control philosophy.
Protect The Product .....
In the pharmaceutical manufacturing environment, a basic requirement is to prevent contamination of a manufactured product by the environment. Pharmaceutical companies invest heavily in clean rooms of various grades, ventilation systems and process equipment designed to maintain a clean environment. Indeed, humans are the largest contributors of contamination in the entire process. The solution: place the process out of reach of the operator, in an Isolator. This enclosure can be cleaned and sterilized before use and the environmental conditions can be controlled during the manufacturing process. Any manual interventions required can be through sealed gloves or suits, and any materials required can enter via an ingenious transfer system, the DPTETM port.
Protect The Operator .....
Drug products are based on chemical compounds. In finished form, the active ingredient (API - Active Pharmaceutical Ingredient) is usually at very low concentrations. However, the API itself is often a hazardous material. Other products, such as Cytotoxic compounds are hazardous even in final dosage form. Operators working with these toxic chemicals, including pharmacists dispensing them, must be protected from them - another application for Isolation techniques.
The "Key" To Isolation Technology
Keeping Operator and Process separated is the essence of Isolation techniques. However the operator must interact with the process. The key to successful operation, is in two parts: Good ergonomic design and effective transfer systems.
Getinge La Calhène's 30 year experience and countless projects with a wide variety of applications means our expert designers know what works and what doesn't. Operators must be comfortable and able to perform their tasks with ease for the process to work efficiently. Everything from isolator layout to the size of gloves must be considered.
And, as the inventor of the technology, La Calhène's name is synonymous with the DPTE (aka Alpha-Beta or RTP) port system that has become the industry standard for transferring materials in and out of isolator enclosures.