Filter:
To make your job easier, the experts at Particle Measuring Systems have compiled these free Cleanroom Standards Classification and Compliance quick-reference cards. A set of handy reference guides that distill critical cleanroom requirements from major regulatory bodies into a concise, easy-to-use format.
This paper explores the application of a high-sensitivity liquid particle counter (Ultra DI® 20 Plus) to optimize ultrapure water (UPW) filtration performance in copper smelting and refining operations, and it demonstrates how sulfuric acid, a by-product of the process, can be refined to meet the high purity standards required by the semiconductor industry.
A compressed gas risk assessment is an important component of your Contamination Control Strategy (CCS) and should start with determining the involvement and final use of the process gases in pharmaceutical industries. The utility of compressed gas is a process system. Compressed gas is an integral part of many processes and can be used in many phases of a process. The design and use of compressed gas process systems must be documented, and the criticality of the system must be determined in a GMP environment (e.g. via a risk-based approach). As stated in Annex 1 in the section on utilities, compressed gases and other utility systems should be properly designed, qualified, maintained, and monitored to prevent contaminants from affecting product quality, stability, and/or efficacy.
Vaporized Hydrogen Peroxide (VHP) serves as a potent oxidizer and has long been acknowledged for its effectiveness in sterilization within enclosed filling isolators. With the rising prevalence of isolator applications, there’s an increasing demand for robust samplers capable of enduring such environments. The MiniCapt® Pro Remote Microbial Sampler features an internal flow path designed to resist the corrosive impacts of VHP.
Microbial sampling of air in pharmaceutical manufacturing facilities is performed using several methods: surface sampling, passive aerosol (air) environmental sampling, and active aerosol (air) environmental sampling. Each of these methods produces a result based on the growth of microbial colonies on the surface of a collection media (typically agar), but the specific instruments and techniques vary between the methods. For all the sampling methods, it is important to be sure that the sample accurately reflects the environmental microbiological condition. This is often measured and discussed in terms of collection efficiency. The focus of this paper will mainly be on active air sampling, but there are sampling characteristics for each type of sampling that ensure the optimized collection efficiency.
Particle Measuring Systems (PMS) recently hosted a webinar Contamination Control Strategies for Innovation and Regulatory Compliance to explain how the implementation of a CCS attempts to address the varied causes of contamination and compromised sterility. Download the paper to get answers to all questions asked.
The increasing attention on driving better product yield performance with advanced technology nodes has drawn reasonable discussion for in-tool monitoring to reduce nanoparticles that can have an impact on yield. With that in mind, Particle Measuring Systems (PMS) launched the new NanoAir™ 10 Condensation Particle Counter that measures particles down to 10 nm and the ParticleSeeker™ Smart Manifold system which is the first-ever manifold designed to handle nanoparticle transport. This product will unlock a new world of monitoring possibilities, providing a look into a current blind spot of the requirements and needs in the industry.
There is an optimum air flow rate within unidirectional environments which is required for Isokinetic particle sampling to act as a sheathing air that washes particles from a potential contamination source away from the process risk before being exhausted from the process area. This ensures that this potential contamination does not extend beyond a field of control. This flowrate was historically defined as 90 feet per minute, which roughly converts to 0.45 m/s. Current requirements suggest…
This paper written by Mark Hallworth, one of the ISO TR 14644 21 committee members, discusses why this new technical report was released, the implications, and next steps for practical application. Complete with explanatory diagrams and a decision tree.
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 approach as well as the data supporting the validation of a single use microbial sampler impactor including a preloaded agar plate. The BioCapt Single Use is a replacement for agar plates in many instances and support continuous monitoring per EU GMP Annex 1.