“Advanced Data Analysis Strategies for Understanding Particle Contamination in Chemical Distribution Systems”
Particle Measuring Systems (PMS) attended SEMICON West in San Francisco, CA last week from July 10 -12. Throughout the event we had many visitors from various semiconductor companies, some looking for advice on specific applications, and others coming to learn more about the different instruments that PMS has to offer for cleanroom monitoring. Many of the booth visitors were from the US, but there were also visitors from the APAC region.
Requirements stated in USP <788>, EP 5.1 and JP 17 demand that injectable solutions are effectively monitored for microcontamination, specifically non-soluble particulates. Potential sources of particle contamination include the manufacturing environment, personnel, and packaging components. In this blog, we examine the history of particulate control in injectables and counting solutions that meet standards set by pharmacopoeias.
Particle Measuring Systems will be attending Semicon West in San Francisco, CA from July 10-12, 2018. Learn about how to improve your yield protection by leveraging our complete contamination monitoring solutions. Industry experts will be available at booth 410 to discuss and address your yield and monitoring challenges.
Pharmaceutical manufacturers must demonstrate compliance with the regulations at every stage before a drug can be released to market. To satisfy these requirements, the products are manufactured in a controlled environment, known as a cleanroom. A cleanroom is the fundamental starting point for contamination control.
Particle counters use lasers which provide intense light to count very small particles. All lasers have a finite lifetime, but that lifetime can be extended or shortened based on how the laser is used. Your cost of ownership will decrease if the laser lasts longer.
As the number of viable particles — colony forming units (CFUs) — impact on an agar plate increases, the probability that viable particles will enter unoccupied space decreases. Particles tend to run in straight lines and adhere to surfaces (agar plates) directly in their path. The impactor design allows viable particles, flowing in straight lines, to accelerate through the slits at an optimal flow rate. This results in viable particles captured at a high biological efficiency.
Regulations have lead to a requirement for an automated, remote monitoring solution. But what are the components of this solution, and how are they implemented? The FacilityPro Environmental Monitoring System follows this format: design, build, install, test, and validate.
Transportation of particles through tubing between the sample inlet and the optics of a particle counter has often been at the forefront of discussion regarding the validity of readings. With the release of the 2008 EU GMP Annex 1 (with an updated draft released in December 2017) the issue of particle loss of large particles has been elevated.
Most Optical Particle Counters use a light source to illuminate a sample volume, an optical system to collect the particle’s scattered light pulse, a process to convert the scattered light into an electrical signal, and electronics to correlate particle size with the scattered light pulse. While the specific design varies greatly between manufacturers (and while the instruments vary with different sensitivity and flow rates), the fundamental principles of optical particle counter operation are quite similar across the industry.