What is a Pharmacy Isolator?
A pharmacy isolator provides a perfectly hermetic and secure containment area. In particular, it is a piece of equipment for the protection of aseptic preparations. Products can be packaged, stored or handled within the main isolator that is completely sterile. Shoulder-length gloves are placed on one wall of the isolator.
The introduction or removal of products can be done with the help of the transfer systems on board the isolator. These systems also allow for the disposal of waste under aseptic conditions and containment.
A wide range of isolators is available on the market. The equipment is generally custom made with the clear objective of ensuring product containment and preventing contamination risks while also guaranteeing the protection of personnel during handling.
Pharmacy isolators have various pharmaceutical applications such as in weighing and dosing operations, innovative therapy drugs, etc.
General Characteristics of a Pharmacy Isolator
In order to ensure proper operation and to guarantee the safest and most reliable containment, the pharmacy isolator must have the following characteristics
- Workstations positioned opposite each other or side by side;
- Just-in-time operation with or without internal storage;
- Unidirectional, turbulent or laminar flow ventilation;
- Negative or positive pressure;
- Secure transfer systems;
- ULPA or HEPA filtration.
The design of a pharmacy isolator should also be designed to meet FDA, GMP, GAMP5, 21 CFR part 11, PIC/S and ISO standards.
The isolator can also integrate specific elements according to its purpose. The following can be integrated into the isolator:
- Various laboratory equipment such as a centrifuge, an incubator, a precision balance for sample preparation,
- Equipment dedicated to powders such as grinders, sifters,
- Equipment more specific to pharma: freeze-dryers for example.
Pharmaceutical Isolator Advantages
The pharmaceutical industry can benefit from the many advantages afforded by the modern medical technology that is an isolator. The sterile environment it offers is superior to what is offered by sterile clean room while the pressureInside the isolator can be negative or positive. Thus, the external environment or the operator can be protected from any contamination in case of anomalies. The isolator is also very effective during the validation of procedures, aseptic processes and sterility tests.
Monitoring and control is easy with the help of the integrated software and options. Recording and adjusting temperatures, humidity levels, pressures etc are also made easy, as are sterility and leakage controls. In addition, the data that will be collected by the isolator will be necessary during inspections by the authorities. Furthermore, the documents provided by the isolator manufacturer must be able to attest to the most rigorous traceability in each stage of the processes implemented.
The equipment requires less investment since it takes up less space, thus reducing renovation costs while the operational costs are also reduced since its maintenance and upkeep are less expensive for those who purchase it.
Jacomex offers a custom-made pharmacy isolator, with options and accessories that meet the constraints of any process.