Exposure to active pharmaceutical ingredients must be kept within acceptable limits. The protection of employees must be achieved primarily by technical measures and not through personal protective equipment. Several containment solutions like glove boxes, islolators, special valves and transfer ports are available. This equipment has to fit to the surrounding, the product requirements and the organisational circumstances. Therefore detailed planning is necessary.
But GMP also has requirements for contamination or the avoidance of contamination / cross contamination as far as possible (see chapters 3 (Premises & Equipment) and 5 (Production) of the EU GMP Guidelines. By introducing the PDE concept (Permitted Daily Exposure) by the European Medicines Agency, occupational medicine and GMP requirements are now based on the same scientific basis, namely on the question: how much exposure is uncritical for a person (whether patient or employee)? This important question has to be answered for both, dedicated and multipurpose equipment.
This Webinar aims at persons from production, engineering and quality, responsible for
- Occupational safety
- Cleaning concepts and contamination prevention
- Design of new manufacturing areas
as well as engineering and plant-construction companies working in containment projects.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The aim of this webinar is to make you a competent partner for dealing with highly active substances - both from an occupational safety and a GMP ((avoidance of cross-contamination) point of view:
- Exposure and how to calculate
- Equipment and containment concepts
- Closed product handling
- Material transfer
- The PDE/ADE concept: how much contamination is allowed?
- Avoiding of cross contamination
- Air born contamination
- Contamination of surfaces
- Verification of the tightness of a containemt system