FAQs from PMEC 2024

At the recently concluded PMEC 2024, our booth attracted significant visitor interest by showcasing innovative solutions addressing Annex 1 compliance challenges.

The frequently discussed points:

1. Testing for the presence of vacuum in containers sealed under vacuum

2. Cleaning tools and processes to address residues of disinfectants

3. Establishing a validated life cycle for secondary garments

We had our global partners showcasing their technologies:

Ackley Machine, USA, demonstrated their high speed and yet compact Servo Drum Laser drilling platform for osmotic release tablets with outputs up to 150,000 products per hour.

ATS SP i-Dositecno, Spain, had fill-finish solutions to offer for a wide range of containers like 3 piece Opthalmic bottles, Nested Vials/ PFS/ Cartridges/ Nasal Pumps/ Preservative free solutions. Also, solutions for the Automated Assembly of medical devices at high-speeds were available.

Wilco AG, Switzerland, had their CCIT machine and HeadSpace Analyser on display. The HSA demonstrated unique features for testing multiple formats without the need for separate change parts.

Vestilab, Spain and Union Micronclean, Thailand, were present under the umbrella of the Alsico group with Gowning and other Clean Room Contamination Control solutions.

Insights on Cleaning Validation

Interest was especially keen on various tools available for cleaning.

Cleaning validation is an increasingly difficult challenge in pharma manufacturing, whether for Injectables, OSD or API.

Regulatory warnings are common across the board, and the Annex 1 requirements regarding cleaning are an important contributing factor too.

Commonly asked questions:

1. We already have a cleaning process in place, yet we are unable to address stains of disinfectant residues and this leads to corrosion.

Answer: Typically, cleaning and disinfection tend to be clubbed as one. Cleaning, as opposed to disinfection requires abrasion. A simple example of this is using a toothbrush to clean the debris from your teeth and following it up with a mouthwash to disinfect your mouth.

Most cleaning practices use low-linting polyester wipes and mops which do not offer much abrasion. Thus, the sticky disinfectant residues remain undisturbed and accumulate on the surfaces leading to stains appearing.

2. When cleaning process equipment like Dryers and Blenders in OSD and API manufacturing, we end up scratching and denting equipment surfaces while trying to remove adhered product. This is not acceptable and is there a way to solve this?

Answer: Cleaning tools are available which can dislodge surface deposits without scratching it.

3. What can be done for preventive maintenance of facility/equipment appearance during periodically scheduled maintenance?

Answer: Periodical usage of specialised cleaning tools which dislodge surface deposits and entrap them to prevent accumulation can be deployed in hands of machine operators who are best placed to notice surface stains/ corrosion in the nascent stages.

4. Cleaning of tablet machine turrets/die pockets is difficult and often one finds residue of previous products. Are there any tools to address this?

Answer: This is part of a larger canvas which deals with the prevention of cross-over contamination in non-dedicated process equipment. Handheld malleable sponges which offer abrasion without scratching and a final wipe down using MiraWIPE for entrapment of are available which can show demonstrable efficiencies.

5. Internals of Silicone transfer hoses are difficult to scrub clean and can lead to cross-over contamination risk. Once washed, these hoses are left to dry and run the risk of microbial contamination due to water droplets on inner surfaces. Is there a way to mitigate these risks?

Answer: Usual cleaning practices for internals of transfer hoses include washing with high pressure water jets and drying with compressed air. While this is good, it does not offer contact cleaning using abrasion which could offer better scrubbing action. Similarly, contact drying using highly absorptive clean materials can considerably hasten the drying process thereby reducing risks of microbial contamination.

6. We manufacture coloured OSD products. It leaves the entire room and equipment surfaces coloured and even though we clean, the surfaces remain discoloured. Is there an effective way to clean the coloured powder from the surfaces?

Answer: Most cleaning practices use low-linting polyester wipes and mops which do not offer much abrasion. Thus the sticky product residues remain undisturbed and accumulate on the surfaces leading to stains appearing. Sahara Mops which offer abrasion as well as entrapment of dislodged products can be used for large surfaces like rooms.

7. We manufacture API. We are constantly plagued with difficult-to-clean stains on Stainless Steel surfaces which further lead to rouging/ pitting/ corrosion. This is remediated by buffing these equipment periodically but that leads to downtime and requalification of production areas. Once buffed, the stains re-appear over time leading to a never ending cycle. How can this be prevented?

Answer: The stains are basically deposits of chemical vapours/ acids/ solvents which accumulate on the equipment surfaces. Metal surfaces are not smooth but have troughs and crests. The cleaning tools and processes used, do not dig out and entrap deposits lodged in the troughs of the metal. Periodical deployment of specific cleaning tools which can dislodge and entrap deposits from the troughs of the metal surfaces can arrest the staining process.

8. Non-viable particle counts are an issue in our clean areas. We use standard antistatic overgowning but still find trouble in containing these counts. What could we do to bring down the NVPC?

Answer: The Factory garment/ Primary garment is largely underrated in its importance in controlling NVPC. Many manufacturing sites use either 100% polyester or cotton as factory garments. Polyester garments create static with every movement and act as magnets to particles. Cotton sheds natural fibres.

Even secondary antistatic gowns are often not evaluated for continuity of static dissipation and are used with bootie soles that are either not conductive or have been worn out thus losing their conductivity.

Comfortable Primary garments which are conductive and also do not require any conductive footwear due to special fabric features are available. These act as primary guardians and can contribute hugely to reducing NVPC.