Kaye Solutions for Glove Boxes / Isolators
Application at a Glance
Clove Box/Isolators in the Pharmaceutical Industry: Optimal Conditions for Maximum Safety and Purity
Isolators, also known as Clove Boxes, find extensive application both in laboratories and in pharmaceutical manufacturing and aseptic production. They play a crucial role in the sterile filling of liquids or powders, loading and unloading of freeze dryers or sterilization tunnels, and general protection against contamination. These systems are also essential for protecting operating personnel when handling, processing, or transporting toxic substances.
Critical Parameters and Test Procedures
For standard-compliant qualification and validation of isolators in the pharmaceutical sector, several critical parameters must be regularly recorded and monitored. These critical process parameters are also part of the IQ/OQ/PQ commissioning as well as the periodic re-qualification of such systems:
- Particle Measurement:
Ensures the purity of the air in the isolator and minimizes the risk of product contamination. - Differential Pressure:
A constant differential pressure is essential to ensure the flow of controlled air and the separation of different pressure zones. - Air Velocity:
Controlled airflow prevents the accumulation of particles and ensures continuous air exchange. - Leak Tests:
Serve to verify the tightness of the system and prevent the ingress of contaminants or the escape of toxic substances. - Temperature Distribution:
Uniform temperature distribution is important for consistent process conditions. Common control methods include measurements at various points within the isolator. - Relative Humidity:
Monitoring humidity prevents the growth of microorganisms and ensures the integrity of samples and products.
Depending on the product being processed or the sterilization method applied, other measurement parameters such as CO2 or H2O2 may count as critical parameters and are thus part of the measurement and monitoring cycle.
Use of Isolators in the GxP Environment
When using isolators in the GxP environment, various standards and guidelines must be followed for commissioning, necessary documentation of critical measurement parameters, and regular re-qualification. Isolators are indispensable in the pharmaceutical industry to minimize product contamination and health risks for personnel. Careful monitoring of critical parameters such as particle count, differential pressure, air velocity, leaks, temperature distribution, relative humidity, and other important parameters is essential for smooth and compliant operation.
Continuous Monitoring of Critical Process Parameters
The continuous monitoring of critical process parameters is an indispensable part of the validation of these processes. Sensors and data loggers continuously capture process parameters, and this data is archived as part of quality documentation. This not only ensures compliance with legal requirements but also guarantees that the products remain in optimal condition at all times.
Technological Solutions from Kaye
Kaye offers first-class solutions for the validation and qualification of isolators with the Kaye Validator AVS, Kaye ValProbe real-time data loggers (ValProbe RT), and the wireless measurement system Kaye ValProbe RF. Additionally, Kaye provides a GxP-compliant solution for continuous monitoring systems with the Kaye LabWatch IoT. These advanced monitoring technologies ensure process safety and high operational efficiency, ultimately improving the quality and integrity of pharmaceutical products.
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