Microbial Archives

Particle Contamination in High-Purity Process Chemicals

Vaporized Hydrogen Peroxide (VHP) Resistance Testing for MiniCapt Pro Microbial Sampler

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 Data Collection environmental monitoring biocapt single use 10 years air sampler for microbiological monitoring

Optimal Microbial Sampling of Air Criteria

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.

Microbial Contamination Monitoring and cleanroom data management

Contamination Control Strategy in the Pharmaceutical Industry – Questions and Answers

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.

Validation of A Single Use Solution for Environmental Monitoring Microbiology

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.