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Covering everything from the technology of particle counting, to the regulatory standards that apply to the pharmaceutical manufacturing industry, to the instrumentation and techniques needed to meet them. The Environmental Monitoring Handbook for Pharmaceutical Manufacturers helps readers understand the topic of EM more holistically and more extensively.
Commonly asked questions are combined with questions submitted during and after the webinar on the NanoAir® and ParticleSeeker® instruments in this document. The questions are answered below by product experts.
Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.
Particle Measuring Systems (PMS) recently hosted a webinar about the new Annex 1 2022 Revision. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by industry expert Mark Hallworth.
This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.
1. Assessment: Outline the CCS
2. Acceptance: Compilation of CCS Documentation
3. Remediation: CCS Evaluation
Annex 1 2008 is the basis for the 2022 version. This paper provides an easy-to-understand side by side comparison of the Annex 1 2008 v. 2022 versions, broken down by section.
The primary importance of environmental monitoring for Advanced Therapeutic Medicinal Products (ATMP) facilities is to demonstrate the highest degree of control over
* The aseptic manufacturing environment
* The potential for cross contamination between batches / manipulations
Read this paper for an easy-to-understand explanation of the meaning of the newest EU GMP Annex 1 2022. The charts provide a section-by-section practical explanation and interpretation of Annex 1.
Continuous monitoring helps ensure the sterility of clean manufacturing within the pharmaceutical industry. In the pharmaceutical field, one of the main objectives required by regulatory guidelines is to preserve the sterility of cleanrooms. Cleanrooms are controlled areas where contamination levels are monitored and managed to meet a defined cleanliness level. To reach this goal, it is important to ensure that each GMP requirement is respected over time.
In discussing acceptable particle losses in tubing, there are many factors. Transportation of particles in tubing between a sample inlet and the optics of particle counters has at many times been at the forefront of discussion regarding the truth of readings. When the validation implications of losses due to various forces are reviewed, the certainty of the result is always in question. So, what are these forces, what are the losses, and what are the acceptable results? This paper addresses these issues to allow for a better understanding of the problem.
