Robert Bosch Packaging Technology GmbH assures with the validation team – the Bosch subsidiary Valicare GmbH together with the validation department of the plant in Crailsheim – protection against microbial contamination during the most critical process of aseptic filling of sterile products in Bosch isolators for pharmaceutical customers worldwide. This process requires protection by the most demanding pharmaceutical cleanroom class conditions which – in addition to adequate cleanroom installations for air conditioning – are assured by preparation of the isolator via bio-decontamination of the inner surfaces using vaporized hydrogen peroxide (H₂O₂). For this purpose, the complete cycle of gassing and rinsing prior to using the isolator for product filling is defined by all critical process parameters like duration, concentration, temperature, and humidity.
Thus the efficient preparation of the isolator for routine usage and for product sterility and patient safety is guaranteed. By demonstrating the killing of biological indicators (BI, special microbial spores of high resistance to H₂O₂), during exposure of all surfaces inside the isolator an efficient bio-decontamination cycle is proven. For this purpose, the validation team takes a deeper look into the customer’s specific loading scheme to define positions which might be critical for bio-decontamination.
By targeted positioning of BIs and subsequent checking of complete killing linked to a certain cycle parameter constellation the proof of efficiency of gassing is given, even for critical positions. These cycle parameters are determined by performing several coordinated decontamination runs.
The validation team documents risk based positioning of BIs, all parameters of cycle development, and evaluates the efficient cycle in its report, which forms the basis for the definition of the recommended parameters for routine usage of the isolator. Validation of this cycle is the last step of the activities at the customer’s site. Stringent incoming goods control of BIs prior to application, concerning identity and resistance, executed by using Bosch isolator completes the validation services for the customers.
- EU GMP Annex 1 revision draft: Manufacture of Sterile Medicinal Products, 20 th of december 2017
- EU GMP Annex 1: Manufacture of Sterile Medicinal Products-revision November
Carmen Riedt, Robert Bosch Packaging Technology GmbH
Senior Manager Qualification/Validation
+49 7951 402 8049
Alena Wagner, Valicare GmbH
Team Leader Qualification/Validation
+49 7951 402 742