Cleanroom Compliance on the Move: AnalytiChem’s UK Site Featured in Cleanroom Technology Magazine

Exploring the power of portable air sampling in meeting modern regulatory expectations

Yoggya De Silva, Microbiology Product Specialist at AnalytiChem’s UK prepared media manufacturing site, explores this vital topic in the July 2025 issue of Cleanroom Technology Magazine. Her article takes a detailed look at how portable microbial air samplers can support effective environmental monitoring in cleanroom environments — a capability that’s increasingly essential in light of the updated EU GMP Annex 1 regulations.

As pharmaceutical and biopharmaceutical manufacturers strive to maintain rigorous standards for product quality and safety, microbiological environmental monitoring (EM) has never been more critical. The 2022 revision of EU GMP Annex 1 emphasized risk-based, continuous monitoring—positioning EM as a cornerstone of a facility’s Contamination Control Strategy (CCS).

📊 Why this article matters

In the article, Yoggya explores how portable active air samplers can strengthen cleanroom compliance by enabling:

• Rapid, flexible monitoring across different cleanroom zones

• Responsive data collection during interventions or investigations

• Support for validation, routine sampling, and incident follow-up

• Improved sensitivity and quantification compared to passive sampling methods

Portable samplers offer a powerful complement to fixed systems, particularly in applications where mobility, fast deployment, or grade A monitoring is essential.

🔍 Practical guidance from a microbiology expert

The article doesn’t stop at theory—it offers practical, actionable advice for professionals involved in selecting or implementing portable microbial air samplers. Topics covered include:

• The pros and cons of different sampling methodologies, such as impaction, filtration, etc.

• Critical selection criteria: flow rate, volume, sensitivity, and regulatory compliance

• The importance of data integrity, operator training, and validated protocols

• Common pitfalls such as incorrect media use or inconsistent calibration

• How to embed portable sampling into a broader cleanroom monitoring strategy

Yoggya also discusses how best practice can turn routine sampling into a proactive tool for risk management, helping manufacturers not just meet compliance requirements, but exceed them.

🧪 A valuable resource for cleanroom professionals

Whether you’re a microbiologist, a quality lead, or part of a contamination control team, this article offers insight into a key area of cleanroom operations. It also reinforces our commitment to supporting customers in achieving the highest standards of cleanroom compliance and operational performance.

🔗 Read the full article in the July issue of Cleanroom Technology Magazine

https://flickread.com/edition/html/686cde0ba9c81?dm_i=8EU,8ZAHT,JWRT2Y,11HIZH,1#11

About the author:

Yoggya De Silva is Microbiology Product Specialist at AnalytiChem’s UK site. She specializes in microbiological EM and cleanroom compliance, with a focus on GMP Annex 1 and real-world contamination control strategies.