Roberto Greselin and Kristin Barrett discuss single-use garments and their role in the contamination control strategy
When it comes to manufacturing medicine for human and animal health, it’s essential to minimise microbial and particulate contamination. This includes protecting against microorganisms that may be transferred to pharmaceutical processes by the operator.
Around 70%-80% of contamination events are linked to the presence of humans carrying microorganisms. And human error is responsible for more than 80% of process deviations. Research also shows that in parenteral drug manufacturing, 30% of microbial detections are found on the surface of operator clothing.
In parenteral drug manufacturing contamination can pose a serious risk to patient health given the route of administration (i.m. or i.v.) and patient conditions. The quality, efficacy, potency and safety of a medication are highly dependent on how the four “Ps” are managed (product; process; production environment; personnel).
Management of the human presence in critical production areas is an essential component of a successful contamination control strategy.
The cGMP Annex I standards also demand a more detailed and specific focus.
Reducing the human presence
Whether it is through separation or automation, reducing the presence of people in critical areas can make a difference.
Wearing the right types of cleanroom personal protective equipment (PPE)
Where the presence of people in cleanroom critical areas is mandatory, what they wear can make all the difference in terms of mitigating product and process contamination.
Frequent and consistent training can help keep cleanroom operators focused on specific behaviours and techniques for minimising the risk of contamination.
There are several solutions that can help manage the presence of personnel in critical areas that are compliant with the new cGMP Annex I guidelines.
A gowning system that includes head-to-toe protection – apparel, gloves, and masks – is essential for personal and process protection. These gowning systems not only offer high levels of protection to personnel, they are also the indispensable “filtration system” that protects the process, product and production environment from the risk of human bio-contamination.
Here are some of the ways in which a single-use gowning system and Quality By Design (QBD) can help achieve contamination control strategy goals.
Appropriate for the donning procedure
The final version of the EU GMP Annex 1 advises that garments should be packed and folded in such a way as to allow operators to don the gown without contacting the outer surface of the garment and to prevent the garment from touching the floor (paragraph 7.13 i).
For sterilised garments, particular attention should be taken to ensure they have been subject to the sterilization process and the packaging should be inspected for integrity before use (paragraph 7.11).
Kimtech A5 sterile cleanroom apparel Clean-Don technology with inside-out folding and built-in snaps that automatically release as the garment is put on help preserve the cleanliness and sterility of the gowning system during the donning phase, makes it easy to adopt proper gowning procedures, and minimises the risk of contamination during the donning process.
Vacuum-packaging provides a visual sterility breach indicator to assure sterility integrity at the point of use.
Appropriate for the process
The final version of the EUP GMP Annex 1 guidelines states that the choice of sterilised garments should be appropriate for the process and grade of the work area and should protect the product from contamination (paragraph 7.11).
Paragraph 7.13i provides further guidance about the different gowning system components (hood, masks, apparel, boots) and how they should be worn and tucked as well as information about garment efficiency for particle and fibre retention and shedding.
Kimtech A5 sterile cleanroom apparel is certified as Class 1 for particle release (Helmke Drum Test). It offers 96% bacteria filtration efficiency (BFE) and 94% particle filtration efficiency (PFE) thanks to its construction material and design features that eliminate gaps in critical areas such as the neck, face, wrist and legs.
Fit and comfort
Fit and comfort in aseptic operations are essential for maintaining ideal body conditions and preventing colony forming units (CFU).
Kimtech A5 apparel features a spunbond/meltblown/spunbond (SMS) fabric that provides strength, cloth-like comfort and a strong barrier against both fine particles and bacteria while maximising airflow to keep the wearer cool and comfortable. This supports Annex 1 paragraphs 7.7 and 7.18.
Cleanroom gloves allow for safe use and contamination-free manipulation of cleaning and process tools. These gloves act as a barrier during cleaning and disinfection operations, reduce the risk of allergic reactions and match the functional needs of the environment (e.g., cleanliness, sterility, wet or dry grip, fit, comfort and sensitivity).
End of life solutions
Your single-use gowning system does not have to contribute to your waste stream and end up in a landfill. Look for a manufacturer-led programme, such as the RightCycle programme, that enables you to recycle your non-hazardous PPE. This can help achieve or exceed sustainability goals by turning used PPE into new consumer goods, such as shelving, flowerpots and lawn and garden furniture.
Protective garments and gloves play a critical role in reducing contamination risk. Make sure to select head-to-toe gowning systems that protect the operator and the process. Single-use, breathable garments that are designed for quality, breathability and comfort are key.
Roberto Greselin and Kristin Barrett are with Kimberly-Clark Professional. For more information visit www.kimtech.eu.