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The Environmental Monitoring Handbook for Pharmaceutical Manufacturers covers particle counting technology, regulatory standards in pharmaceutical manufacturing, and the instrumentation and techniques required for compliance. It offers a holistic and in-depth understanding of Environmental Monitoring (EM).
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.
The purpose of the Growth Promotion Test (GPT) is to determine the appropriateness of the culture media to be used in environmental monitoring sampling. The medium is challenged with a small number of microorganisms to assure the nutritive properties, functionality and media quality are adequate for the detection and enumeration of microbial contaminants.
Some users believe it is necessary to divide the particle counts of non-volumetric particle counters by the counting efficiency (CE) at the lower limit to establish the “true” concentration of particles in the fluid system. Other users do not understand why two, similar-sized channels of particle counters with different limits of detection do not report the same value. This paper will discuss the science behind these differences and alleviate concerns that come from the characteristics of non-volumetric particle counters.
Aseptic Processing is aimed to maintain the sterility of a product via the assembly from sterile components. It is implemented to prevent microbial contamination.
This poster/paper presents data supporting the validation of a single use microbial sampler impactor including a preloaded agar plate.
The Technical Committee (ISO/TC209) responsible for ISO 14644, the set of Standards governing cleanrooms and associated controlled environments, looked at the need for a new document to aid users in the application of airborne particle counters; especially considering the new revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) describes the application of particle counters for classification and monitoring to provide sufficient proof that the cleanroom performance both meets the required standard and is demonstrated to be maintained within ‘normal’ operating conditions.
A cleanroom with unidirectional airflow utilizes a controlled, steady velocity of air in parallel streamlines that move in one direction to minimize the potential movement of contamination. Unidirectional cleanrooms are typically designed using laminar airflow hoods that direct the air, and the airflow is designed to wash particles from a potential contamination source away from the process risk before being exhausted from the process area.
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
