The Devil Is in the Details

Galenisys Newsletter : October 2026

Table of Contents

• TALES FROM FARAWAY PHARMA: THE FLY IN THE OINTMENT
  Almost Perfect in Senegal
  By Steve Biddulph

• I CAN SEE CLEARLY NOW …………THE BUGS HAVE GONE
  Decontaminate with fogging and fumigation
  By Richard van Duyse

• PROJECTS HAVE TRAFFIC LIGHTS
  Learn to read them: anticipate & avoid delays
  By Tony Dunford

• IF IT ISN'T WRITTEN DOWN, IT DIDN'T HAPPEN
  As important now as ever
  By Richard van Duyse

TALES FROM FARAWAY PHARMA: THE FLY IN THE OINTMENT

by Steve Biddulph

Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.

“THE FLY IN THE OINTMENT”
Almost Perfect in Senegal

Our Quality Team had spent many hours with Engineering and Industrial Operations in putting together design & construction standards for purified water systems. Since project engineers had recently installed a new purified water system in the plant in Senegal, it was time to audit it on site, so off we went to Dakar.
At the site presentation the site director happened to mention that he originated from Yvetot in France and still had a home there. Two of the three auditors also came from Yvetot (it’s a “small world”sometimes).

Firstly, we examined the “as built” drawings and compared them with the corporate standards. Things looked fine. Next were several sessions in the facility for physical checks which involved looking at the valve and vessel types, welds, measuring instruments and their calibration, materials of construction, falls on pipe work, pipe coding, and where installed insulation, together with other features, and operating records, etc etc.

The purified water system was a textbook system in terms of compliance, except that the system had been hard piped into the drains and the site was in an area prone to flooding!
So, we needed to show this error to the site director, the engineering head, and other folks, and explain why it was serious. To do this we needed to go through the warehouse.

The warehouse visit was interesting, and pest control was much in evidence as were the monitoring records.

The only “fly in the ointment” in terms of pest control, or should I say “the only lizard in the ointment” was a large monitor lizard, as big as a dog, which suddenly appeared at the end of one row of pallet racking.

Everybody jumped in surprise including the aforesaid lizard which sped away into the warehouse double walls.

In pest control don't overlook the “little things”.

Steve Biddulph

I CAN SEE CLEARLY NOW …………THE BUGS HAVE GONE

Decontaminate with fogging and fumigation

By Richard van Duyse

Experienced international vaccine industry consultant. Specialized in project & operational management, facility design, start-ups, & technology transfers. Bachelor of Applied Science (B.Sc.).

Thanks to this article from Richard, I can clearly see the difference, advantages, and disadvantages, of decontaminating clean rooms by fogging or fumigation; and I hope it helps you as well.
The Editor

Fogging & Fumigation are both used in the Pharmaceutical Industry for environmental decontamination in manufacturing and other controlled (clean room) areas. They reduce microbial contamination in rooms, on equipment surfaces, and in difficult-to-reach areas. However, they differ in the way the antimicrobial agent is generated, dispersed, and applied.

What is “fogging”?
Fogging is the process of dispersing a disinfectant as very small liquid droplets creating a “fog” throughout an enclosed area using specialized equipment such as a ULV (Ultra-Low Volume) fogger, or thermal fogger.

The disinfectant is generally a liquid formulation, such as an appropriate hydrogen-peroxide, peracetic-acid, or other validated disinfectant formulation. The generated droplets settle on exposed surfaces to provide antimicrobial activity. Other common agents are Quaternary Ammonium Compounds (QACs) - Isopropyl Alcohol (IPA); & mainly for non-sterile areas - Sodium Hypochlorite.

Fogging is used in:
• Decontamination of manufacturing and packaging rooms.
• Periodic disinfection of cleanrooms and controlled environments.
• Treatment of difficult-to-reach areas, corners, and equipment surfaces.
• Decontamination of warehouses or material-transfer areas, where appropriate.
• Supplemental environmental disinfection as part of a validated contamination-control program.

It’s potential advantages are it:
• Can distribute disinfectant over a relatively large area.
• Reach areas that may be difficult to clean manually.
• Be useful for periodic or terminal room disinfection.
• Can be rapidly applied when the process is properly designed.

Limitations:
• Effectiveness depends strongly on variables - droplet size, concentration, contact time, room configuration, and surface coverage.
• Excessive moisture can damage equipment or materials.
• The process must be validated. Visible fogging only means nothing.

What is “fumigation”?
Fumigation involves filling an enclosed space with an antimicrobial chemical in gaseous or vapor form rather than as liquid droplets at a controlled concentration for a specified exposure period.

Vaporized hydrogen peroxide (VHP) is the most widely used agent for room or enclosure bio-decontamination. Other fumigants have been used eg: Formaldehyde Gas (limited use due to safety concerns) - Chlorine Dioxide (ClO₂) - Ozone (O₃) in specific applications; & Ethylene Oxide (EtO) for selected equipment under strict controls; if safety, regulatory, and material-compatibility concerns have been addressed.

Applications:
• Decontamination of pharmaceutical cleanrooms.
• Decontamination of isolators and restricted-access barrier systems (RABS), where validated.
• Decontamination of pass-through chambers and material-transfer systems.
• Decontamination of equipment interiors and enclosed spaces.
• Periodic or emergency decontamination of controlled environments.

Advantages: the vapor or gas
• Can penetrate and distribute throughout complex enclosed spaces.
• Can provide highly controlled whole-room or enclosure bio-decontamination.
• Process is particularly useful for enclosed equipment and barrier systems.
• Process can be monitored using concentration, humidity, temperature, and exposure-time parameters.

Limitations: the process requires:
• specialized generation, monitoring, and aeration equipment.
• That materials and equipment be assessed for compatibility.
• careful cycle development and validation.
• That residual fumigant be reduced to an acceptable level before personnel re-entry.

During either Fogging & Fumigation personnel must be protected from exposure to the process or the agents, and preferably absent from the areas being treated, because of significant safety risks.

If used either process should form part of a validated contamination-control strategy, covering:
• Demonstration of microbiological efficacy by the required log reduction of relevant microorganisms.
• Validation including representative worst-case locations surfaces.
• Room characteristics since volume, geometry, air handling, temperature, humidity, and airflow can significantly affect efficacy.
• Material compatibility including stainless steel, plastics, elastomers, electronics, filters etc.
• Establishing exposure controls, interlocks, warning systems, ventilation, and re-entry criteria for personnel safety.
• Assessment of chemical residues relevant to product quality and personnel safety.
• Routine monitoring to maintain validated operating parameters.
• Documentation of related procedures, qualification, validation, deviations, maintenance, and periodic review.
In summary both “fogging” and “fumigation” can be very useful but require execution with thorough preparation and understanding of the process.

Richard van Duyse

PROJECTS HAVE TRAFFIC LIGHTS

Learn to read them: anticipate & avoid delays

By Tony Dunford

Halfway down the hill to Evian there's a complicated crossroad (“Le X d’ Evian”) where traffic regularly blocks up. Just starting is 7 months of work to create a welcome roundabout instead. Meanwhile of course there will be an extended wait at traffic lights (which at least indicate the number of seconds before they change to change from red).

Pharma and biotech projects have traffic lights as well although they're not always obvious and can change out of sequence. Nevertheless, it's very useful to have a rough idea where a project is at: either “RED, YELLOW or GREEN” on the path towards eventual completion.

The early phases of a project are where it's being “Scoped” & the “PEST” factors considered, it’s clearly on “YELLOW” as it's not yet been fully costed, or funded by owner(s) / sponsor(s) financial approval. This earIy phase - working up the Scope to a Basic Design, requires only modest funding, particularly if experienced consultants like Galenisys are involved.

Years ago I worked on a transdermal patch project in Europe at a very good site equipped with wide web coaters for multi-layer film. There my job was to help them obtain a Manufacturing Licence by training up staff, and implementing a GMP compliant QA system ie in the YELLOW phase of the project.

However, 12 months into the project it became obvious that validated cleaning of the existing equipment, between pharma non-pharma products was unfeasible; & new segregated coaters & clean rooms etc would be required. Unknown to the holding company was that the local Sales Director had concluded a binding fixed price contract with the pharma client without allowance for such costs, in effect rendering the embryonic project unviable. He’d “put the cart before the horse”.
The Project Traffic Lights abruptly changed to RED. (And the Sales Director left!).

Normally after Detailed Design and full approval of a costed project the light turns to GREEN. This is usually a very enjoyable period before snags have been discovered, or disputes arisen!

But imagine after eg a change in government, or a key contractor stops getting paid, the traffic light might start flashing YELLOW, at least in the minds of people inputting to the project.
Do remember long “yellow period delays” always substantial increase costs.

Planning in advance, and structuring the project well, can avoid a lot of “yellow light” incidents. The integrated VMP, Change Control procedure, Quality Plan, Work Breakdown Structure, Roles & Responsibilities Matrix, etc will all help to keep the lights on green, & on the smooth path towards successful completion……
plus the well-deserved celebration luncheon, grand opening, & hopefully cash bonus.

Tony Dunford

IF IT ISN'T WRITTEN DOWN, IT DIDN'T HAPPEN

As important now as ever

By Richard van Duyse

Experienced international vaccine industry consultant. Specialized in project & operational management, facility design, start-ups, & technology transfers. Bachelor of Applied Science (B.Sc.).

"If it isn't written down, it didn't happen" is probably the best-known basic principle of cGMP, & just as valid in this era of electronic data. Years ago when we were drafted into QA to help prepare for an FDA inspection, we joked that GMP meant Great Masses of Paper. However later were very relieved when we could quickly produce the docs the Inspector demanded.

But when it’s a flawed document, things can go seriously wrong. Here’s the famous example:

During a rigorous FDA inspection at a major manufacturer of sterile injectables, an inspector checked the filling line. He’d reviewed the documentation for a batch that had just been successfully completed. Everything looked perfect: the upstream temperature logs and the sterility tests etc were all “good”; & signatures were in the right places.

The inspector then walked over to the operator responsible for cleaning the filling machine.
• Inspector: "I see that the machine is gleaming and completely clean. Did you just clean it according to the SOP (Standard Operating Procedure)?"
• Operator (proudly): "Yes, absolutely! I took extra time for it. Every part has been disinfected and is ready for the next batch."
• Inspector: "Great work. May I see the logbook where you signed off on this cleaning?"
• Operator: "Oh, that form is still on my desk on the other side of the cleanroom. I was just about to fill it out and sign it, now that I'm all finished."

“Gold dust” for the inspector! who skewered the operator with…..

"Sir, as far as I am concerned, this machine is not spotless at the moment. In fact, because you did not document it immediately, this cleaning officially never took place. If you pick up a pen right now and write down that you cleaned it at 2:00 PM, you are falsifying the timeline. If you proceed to use it for production now, I will reject the entire next batch due to the equipment's unknown status."

The operator had to repeat the entire cleaning procedure, which took hours, solely to ensure the documentation aligned with the actual operation.

The paper trail - the audit trail - is the product.

This example is not bureaucratic overkill, but a matter of absolute necessity. The hard logic (and reality) of the approach is that in the pharmaceutical industry, a patient cannot tell just by looking at a pill or a liquid whether it is safe. If a problem with a medication comes to light later, the manufacturer must be able to prove, with minute-by-minute precision, who worked on it, what was done, when it happened, and what materials were used, in order to guarantee the safety of thousands of patients. Hence “the paper trail (the audit trail) is the product”.

In next month’s Newsletter I’ll go deeper into this vital subject of data integrity.

PS: The Inspector could also have taken his finding as indicative of sloppy application of the SOP, poor training, and area supervision, in general; and insisted on a more intensive inspection of compliance in these areas

Richard van Duyse