Standards for monitoring particulate and microbials in compressed gases.
Lasair Pro and HPD III for Monitoring nonviable particulate in gases.
Compressed gases can be viewed as critical utilities in many industries. Various types of compressed gases are used in both direct and indirect product contact in cleanroom environments. The requirements for monitoring compressed gasses in the Pharmaceutical, and Cosmetics & Personal Care industries will be explored here.
Pharmaceutical Industry
In the Pharmaceutical industry, several different types of compressed gasses are used for different products and applications. They are used in direct and indirect product contact during the manufacturing process, in various levels of clean room and hood classes. In order to ensure the highest level of product quality and safety, viable particulate and non-viable microbial monitoring is required worldwide by ISO 14644, 21 CFR Part 11 in the US and EU GMP Annex 1 in Europe. Additionally, there are other regulatory standards in each region of manufacture that may add levels of quality to these internationally recognized standards of GMP. The regulatory agencies of each region of manufacture oversee the adherence to their local laws. If manufacturers intend to export their products to other countries, they are subject to oversight, audit, and customs protections by the importing country.
Cosmetics & Personal Care Industry
In the Cosmetics and Personal Care industry, monitoring compressed gasses for viable particulate was made a requirement worldwide when the International Cooperation on Cosmetic Regulation (ICCR), a joint effort by the US, EU, Canada, Japan & Brazil, committed to implementing ISO 22716 wherever possible in their respective regions. The ICCR was formed to pave the way for the removal of regulatory obstacles to international trade while maintaining global consumer protection. The ISO 22716 standards were implemented to ensure the highest purity and safety of ingredients, quality of manufacture, and controlled product handling in personal care products. Of course, there are other quality standards worldwide, such as the FDA Food, Drug, and Cosmetic Act in the US and the EU Cosmetics Regulation 1223 in Europe, among many others.
The products made under the Cosmetics and Personal Care industry are not held to the same standard that Pharmaceutical products are because they are primarily topical and do not contain pharmaceutically active ingredients. If products intended to be sold by the Cosmetics industry are delivered orally or by injection, their manufacture is held to the same higher regulatory and quality manufacturing standards as the Pharmaceutical industry.
Particle Measuring Systems offers a wide range of solutions that are compliant with the latest ISO/GMP requirements to ensure contamination control in critical manufacturing environments. This includes the monitoring of compressed gases.
Compressed Gas Kit and MiniCapt® Mobile for Monitoring viable organisms in gases
Click here to learn more about monitoring viable and non-viable particulate in compressed gasses in the Pharmaceutical and Cosmetics industries.
Products:
HPD III High Pressure Diffuser – The HPD III Aerosol Monitoring Accessory is used for monitoring non-viable particulate and is compatible with non-toxic, non-flammable gases such as Clean Dry Air (CDA), Argon, and Nitrogen.
Compressed Gas Kit – The Compressed Gas Kit from Particle Measuring Systems, in conjunction with the MiniCapt Mobile microbial sampler, allows you to monitor for viable organisms in compressed gases in flexible locations around your facility.
See links to additional supporting resources below:
Webinar:
Effective Compressed Gas Contamination Monitoring: Particles and Microbials
Application Notes:
Sampling Compressed Gas with the Lasair III Particle Counter
Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions
Applicable Standards:
Pharma: 21 CFR 211 & cGMP, ISO 14644-2, EU GMP Annex 1,
Want to read more? Jump to other posts in this series:
Part 1 of 2: Standards (You are here!)
Part 2 of 2: Compressed Gas Contamination Monitoring Program
