There has been a lot of recent discussion concerning the necessary changes to GMPs for capping due to the updates to Volume 4 of the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Please take a minute to review the recent trends reflected in Annex 1, Manufacture of Sterile Medicinal Products:
1. Vial capping can be undertaken as an aseptic process using sterilized caps or as a clean process outside the aseptic core. Where this latter approach is adopted, vials should be protected by Grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a Grade A air supply until the cap has been crimped (120).
2. The container closure system for aseptically filled vials is not fully integral until the aluminum cap has been crimped into place on the stoppered vial. Crimping of the cap should therefore be performed as soon as possible after stopper insertion (118).
3. As the equipment used to crimp vial caps can generate large quantities of non-viable particulates, the equipment should be located at a separate station equipped with adequate air extraction (119).
4. Vials with missing or displaced stoppers should be rejected prior to capping. Where human intervention is required at the capping station, appropriate technology should be used to prevent direct contact with the vials and to minimize microbial contamination (121).
5. Restricted access barriers and isolators may be beneficial in assuring the required conditions and minimizing direct human interventions into the capping operation (122).
Some of the many Bosch solutions available include a reject station prior to capping for the detection and rejection of high and missing stoppers, as well as the ability to provide Grade A Laminar Flow hoods and extensions.
Here is a link to a short presentation to provide more information on a vision system, which we recommend for detection of raised and missing stoppers.
At Bosch, we are committed to providing solutions to address your developing needs. Please contact us at 763-424-4700 with any questions or concerns regarding Bosch Packaging products.