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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.
Discover the importance of compressed gas risk assessment in pharmaceutical manufacturing. Learn how to ensure product quality and compliance through effective management of compressed gas systems, including their design, operation, and monitoring.
Ensure the integrity of your manufacturing processes with our comprehensive guide on maintaining the cleanliness of compressed air systems. Discover essential guidelines for identifying contaminants, monitoring practices, and preventive maintenance strategies to meet regulatory standards. Learn how Particle Measuring Systems can support you in achieving optimal air purity and safeguarding product quality.
In this blog, we’ll explore how modern innovations, like the BioCapt® Single-Use microbial impactor, can enhance microbial air sampling efficiency while reducing the risk of false positives in cleanrooms.
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.
In the pharmaceutical manufacturing industry, ensuring sterility and minimizing microbial contamination are critical for maintaining product quality and safety. Microbial sampling is a key component of environmental monitoring, and understanding the optimal criteria for sampling can significantly impact the effectiveness of sterility assurance programs. Learn about optimal microbial sampling criteria here.
In the pharmaceutical industry, maintaining stringent contamination control is not just a regulatory obligation but a fundamental aspect of ensuring product safety and efficacy. The EU GMP Annex 1 outlines the importance of a Contamination Control Strategy (CCS) for sterile drug products, emphasizing the need for a structured approach to manage risks and maintain compliance. We recently hosted a webinar discussing these strategies in detail. To help navigate this complex field, we’ve compiled a list of frequently asked questions from our experts.
Our Facility Pro® environmental monitoring system showcases exceptional performance during internet outage events, ensuring uninterrupted and continuous cleanroom monitoring and control. Facility Pro is a vital component of our Facility Monitoring Systems (FMS) product line, integrating sampling, reporting, and data retention of particle, microbial, and environmental data.
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.
