PHSS News | Open Access | Published 2 July 2026

PHSS News

Dear Members,

As we head into the summer, we continue to focus on bringing our membership educational and knowledge development opportunities.

In April we hosted the 2 day virtual Aseptic workshops, supported by Di Morris, Matt Cokely and David Collins.

Day One: Di Morris - PNR Pharma introduced the session, explaining the challenges and high-risk areas of aseptic processing.

Matt Cokely and David Collins - Ecolab Life Sciences covered four areas during these workshops:

• Contamination Control Strategy (CCS): The role of cleaning/disinfection in your strategy

• An overview of Disinfectant efficacy testing (DET) and regulatory expectations

• Cleaning vs disinfection: When to clean, when to disinfect and the management of residues

• Disinfectant validation incorporating mechanical action (wiping/mopping): Cheating the test or complying with Annex 1?

Dr. Ana Kuschel - West Pharmaceuticals Services & Alan Kelly - PM Group

Risk or Readiness? Why 2026 Will Be the Defining Year for QRM and Contamination Control Strategies

This session helped attendees understand what regulators now define as "ready": integrated, data driven QRM; harmonised packaging specifications; and CCS practices that reflect real world contamination risk awareness. Participants will gain clarity on the audit themes shaping 2026 and how to strengthen systems to meet modern regulatory expectations.

Participants who joined these workshops were provided with a sharper understanding of what "ready" looks like in 2026, not just compliance, but confident, data backed, risk aware process control that stands up to inspection scrutiny and supports sustainable sterility assurance for the future.

Next up in our schedule were 4 sessions hosted by James Drinkwater, focused on Airborne Contamination Control: Protective Airflow and Airflow Visualisation

The PHSS protective Airflow visualisation training course provides insight into the characteristics of Protective airflow, including First Air protection as defined in EU GMP & PICS Annex 1, and considers the design and qualification of airborne contamination control in Aseptic manufacturing.

The course aligns with training provided by the PHSS to international regulatory authorities on Airflow visualisation, supporting published research on the characterisation of protective airflow and 'First Air', and using a set of 'Rules' to provide a framework for acceptance criteria in airflow visualisation studies.

The airflow visualisation research presented applies the science of Computational Fluid Dynamics (CFDs) and its connection to Smoke study airflow visualisations.

The value of CFD in the design phase lies in its ability to improve aerodynamics, provide knowledge of airflow patterns, flow vectors and velocity profiles in order to improve protective airflows, including First Air protection, which in turn provides better airflow visualisation. Smoke study outcomes are increasingly recognised by industry and regulators

If you were not able to attend either the Aseptic Workshop or Airborne Contamination Control sessions, you can access recordings via PHSS website https://phss.glueup.com/event/airborne-contamination-control-protective-airflow-and-airflow-visualisation-172598/

As a Reminder, all PHSS member receive 30-day free digital access to the latest Technical Monographs and Guidance documents. These documents provide valuable insights and information to support your learning journey and navigating daily

• PHSS Contamination Control Strategy Guidance Pack

• PHSS Clarity In GMP – Assurance Of Sterility For Container Closure

• PHSS Clarity In GMP Guidance – Cleanroom Airflow Definitions

• PHSS Clarity In GMP Guidance Note Biological Indicators

• PHSS Clarity in GMP Guidance: Pharmaceutical Isolator Leak Integrity Classes

• PHSS Clarity In GMP – Qualification Of No-Touch-Transfer NTT

• PHSS Guidance E-Document For Cold Storage Temperature Monitoring And Mapping

• Bio-contamination Characterisation, risk profiling, control, monitoring and deviation management – PHSS Technical Monograph No 20 Bio-Contamination

• Restricted Access Barrier Systems (RABS) Definition, Classification, Specification and Use for Aseptic and Related Processing – PHSS Technical Monograph No 15

  
  

And more https://www.phss.co.uk/product-category/publications/

Upcoming events: Please keep connected to hear more about opportunities to connect and engage with SME’s, through PHSS events.

2026

• Annual Conference – 16th September SAVE THE DATE

• Surface Contamination Control (virtual training) – October

• Freezer Drying - More to follow

• QP Forum – 5th November SAVE THE DATE

2027

• Radio Pharmaceuticals (virtual)

• Contamination Control Strategy (CCS) Training (virtual)

• Aseptic workshops 2 half day (virtual) - April

• CMC/GMP (virtual)

• Steriles Conference – June

• Annual Conference – September

• QP Forum – November

***ARE YOU MISSING IMPORTANT INFORMATION AND ACCESS TO GUIDANCE DOCUMENTS***

JOIN NOW

• PHSS-exclusive monthly regulatory update synopsis, providing a one-stop shop

• 30-day free digital access to the latest Technical Monographs and guidance documents

• Quarterly online peer review copy of the EJPPS Journal

• Member-Exclusive Access at a Significantly Reduced Rate at the influential Annual Members’ Conference

• Opportunities to connect and engage with SME’s

Thank you to our membership and industry collaborations for your ongoing support.

Best wishes to you all

Jenni Tranter,

PHSS Chair

July 2025