Particle Measuring Systems (PMS) articles

Abstract

The EU GMP Annex 1 Guide requires continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counting system, such as the Airnet II or IsoAir 310P. This is because the risk of contamination of finished product is very high and the greatest risk, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also a random generator of those particles. These are not all inert particles;

Abstract

A syringe sampler represents the simplest delivery system for precisely delivering a sample to the particle counter. The precision motion of the syringe drive produces a steady flow of fluid that is free of pulsations that are typical of most pumps suitable for chemical delivery. An overview of the syringe sampling system is provided.

Introduction and Goal

Compressed gases are broadly used in medicinal production facilities. A variety of different gases can be introduced into the process at various stages of a product’s manufacture for different reasons. Compressed gases such as air, nitrogen, and carbon dioxide are regularly used in cleanrooms and are frequently employed in purging or overlaying. The cleanliness of compressed gases used during the pharmaceutical manufacturing process is a ve

Abstract

This paper discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP(April 2007), EP 5.1 and JP 15 release information. These standards demand that injectable solutions are effectively monitored for microcontamination, specifically non-soluble particulates.

Abstract

A non-sterile nasal spray production process is presented and examined with the aim of eliminating the gamma terminal sterilization step. Several key points, including but not limited to process design, bioburden control, and environmental monitoring (EM) are considered alongside this endeavor. By implementing the best practices dependent on these factors, sterile filtration prior to filling can be achieved.