In a sterile manufacturing environment, personnel represent one of the greatest possible causes of contamination. A cleanroom can have a suitable HVAC system in place, good equipment, validated cleaning practices and effective environmental monitoring systems; nevertheless bad working practices can lead to issues with contamination control.
It is obvious, therefore, that gowning is not merely the act of putting sterile garments on prior to entering the cleanroom. Rather, it is a system to minimize contamination caused by personnel.
Proper gowning procedures incorporate the flow of personnel, classification of cleanrooms, design of garments, hand hygiene, design of changing rooms, technique of gowning, qualification and monitoring of personnel. The particular sequence will be developed on the basis of the contamination control strategy established for the site and risks identified.
Therefore, to minimize the risk of contamination, sterile manufacturing facilities use personnel gowning as a part of their contamination control measures.
An effective gowning protocol must:
- reduce any contamination generated by personnel
- restrict transfer of contamination between areas
- protect important areas
- ensure cleanroom class is kept
- minimize the risk of microbial contamination
- make personnel behave in compliance with policies
It is important to realize, however, that gowning is just one of the elements of contamination control and will not substitute poor facility setup, HVAC malfunction, bad cleaning or personnel movement.
For example, entering a lower-grade controlled area will often require different gowning protocols as compared with working directly in Grade A.
Common sterile manufacturing clothes include the following:
A typical order of personnel movement may include:
Uncontrolled Area → First Change Area → Hand Hygiene → Gowning Area → Final Gowning → Airlock → Cleanroom
However, the specific route adopts the design of an organization. The principal of such an approach is that progress is done from less controlled to more controlled locations while avoiding possible backward contamination. The personnel should not be moving unnecessarily between the clean area and the less-clean area.
Personnel needs to accomplish the following tasks:
1. Go to the changing room in appropriate conditions,
2. Discard all personal jewelry, watches, cosmetics or any other prohibited personal items,
3. Take off all the outdoor clothing according to the correct procedure,
4. Examine hands and fingernails,
5. Carry out the required hand washing or hand sanitizing procedure,
6. Ensure that the working garments have passed their valid period and expiration date,
7. Examine the sterile garment to see if they have sustained any harm.
Personnel should not enter the cleanroom if their conditions can lead to an increase in contamination risk.
This is one of the critical steps when using a gown. If something sterile touches something non-sterile, it will be useless in preventing contamination.
Personnel must ensure:
Such qualification presupposes:
Monitoring may involve:
Here are a few common of these practices:
The CCS will include the following aspects:
Use visual guides: Visual guides (pictures or drawings) will be superior to long explanations in many cases.
Avoid mixing clean and dirty tasks: Changing rooms must be designed in a way that the personnel should know exactly where to go.
Restrict the necessity of requalification: Gowning must be considered not as a single procedure.
Record employee supervision: If gowning is regularly disregarded, it means that the procedure needs to be improved.
Evaluate the process after any changes: After any changes are done, a gowning check must also be done.
Gowning is an important part of contamination control in sterile production, but the success of gowning does not rely solely on the garment being worn. Rather, several factors need to be considered such as the order in which the gowning steps are executed, the way the garments are handled, how people move in and out of the gowning area, the practices followed in washing hands, etc.
The best gowning program will recognize that personnel are an indispensable part of contamination control. It will therefore provide training that leads to the certification of personnel, routine monitoring and supervision. By having an understanding of the contamination risk involved in the gowning actions, personnel can be expected to observe the gowning requirements better.
One important practical tip is that the final gowning action should allow personnel access to the sterile area without excessively touching themselves, their equipment, doors or any potentially contaminated surfaces.
Proper gowning procedures incorporate the flow of personnel, classification of cleanrooms, design of garments, hand hygiene, design of changing rooms, technique of gowning, qualification and monitoring of personnel. The particular sequence will be developed on the basis of the contamination control strategy established for the site and risks identified.
Why Gowning Matters in Sterile Manufacturing
Individuals continuously shed skin and hair flakes, fiber and microbes. Every action has the potential to increase contaminant generation.Therefore, to minimize the risk of contamination, sterile manufacturing facilities use personnel gowning as a part of their contamination control measures.
An effective gowning protocol must:
- reduce any contamination generated by personnel
- restrict transfer of contamination between areas
- protect important areas
- ensure cleanroom class is kept
- minimize the risk of microbial contamination
- make personnel behave in compliance with policies
It is important to realize, however, that gowning is just one of the elements of contamination control and will not substitute poor facility setup, HVAC malfunction, bad cleaning or personnel movement.
Gowning Requirements Depend on the Cleanroom
Any gowning protocol used should be appropriate for the cleanroom classification and the corresponding operation being carried out.For example, entering a lower-grade controlled area will often require different gowning protocols as compared with working directly in Grade A.
Common sterile manufacturing clothes include the following:
- Exclusive clothes for cleanroom
- Beard and hair covers (if required)
- Face mask
- Gowns or coveralls that comply with cleanroom regulations
- Leg coverings or footwear for cleanroom
- Safety glasses or goggles where required.
Personnel Flow Should Be Defined First
The changing route for personnel should be determined before establishing the order of gowning.A typical order of personnel movement may include:
Uncontrolled Area → First Change Area → Hand Hygiene → Gowning Area → Final Gowning → Airlock → Cleanroom
However, the specific route adopts the design of an organization. The principal of such an approach is that progress is done from less controlled to more controlled locations while avoiding possible backward contamination. The personnel should not be moving unnecessarily between the clean area and the less-clean area.
Preparation Before Gowning
Effective wearing of garments starts prior to putting the first garment.Personnel needs to accomplish the following tasks:
1. Go to the changing room in appropriate conditions,
2. Discard all personal jewelry, watches, cosmetics or any other prohibited personal items,
3. Take off all the outdoor clothing according to the correct procedure,
4. Examine hands and fingernails,
5. Carry out the required hand washing or hand sanitizing procedure,
6. Ensure that the working garments have passed their valid period and expiration date,
7. Examine the sterile garment to see if they have sustained any harm.
Personnel should not enter the cleanroom if their conditions can lead to an increase in contamination risk.
Normal Gowning Process
This particular process should be based on a site-specific SOP, although processes and the designed system may change. Typically, this process starts from the simplest cleanest activity and ends with sterile garments.Step 1: Remove Personal Items
Jewelery, watches, phones, cosmetics and other objects should not be carried into the gowning area. Personal belongings can bring dust and bacteria into the cleanroom and disrupt the gowning process.Step 2: Perform Hand Hygiene
Washing hands in the approved way needs to be performed properly and carefully. It’s crucial as hands will then come into contact with the gowns and gloves.Step 3: Put on Hair and Beard Cover
Hair and beard need to be hidden completely. It should be fastened in a way that no part of the hair stays uncovered.Step 4: Put on Face Mask
The nose and mouth should be entirely covered by the mask. Personnel must refrain from unnecessary contact with the mask after it has been adjusted.Step 5: Wear Cleanroom Garments
Employees in cleanroom facilities may need to wear specific pants, shirts, overalls or other types of cleanroom garments according to the type of facility. Clothing needs to be handled with care, preventing contact with the ground and any surfaces.Step 6: Wear Sterile Garment
If people work with aseptic methods, they should wear sterile gowns or overalls. People must open the garment without letting its external surface come into contact with any contaminated surfaces.This is one of the critical steps when using a gown. If something sterile touches something non-sterile, it will be useless in preventing contamination.
Step 7: Wear Sterile Footwear
People must wear sterile or dedicated shoes properly, based on the facility's transition process. Personnel must avoid crossing the lines drawn between the clean and not clean areas.Step 8: Wear Sterile Gloves
When putting on gloves it is necessary to use an aseptic process, so that the hands do not touch the outside surface of gloves. It is necessary to sterilize the gloves after putting them on if it is required before entering an area.The Importance of Gowning Technique
Acquiring the right clothing is not enough. The way you wear and treat the clothing is just as critical.Personnel must ensure:
- They do not touch the floor with clothing.
- The clothes do not touch any uncontrolled surface.
- They do not touch their face after wearing the clothing.
- There is no need to make corrections to the clothing.
- There is no contact of the skin with sterile gloves.
- They work carefully and without rush during the process of gowning.
- They do not repeat the use of non-reusable clothing.
Gowning Qualification
Only qualified personnel can work in the areas of sterile production.Such qualification presupposes:
- Training in gowning
- Demonstration of gowning in practice
- Observation of trained personnel
- Use of microbiological tests
- Testing the dress
- Participation in qualification programs on applying aseptic technology.
Personnel Monitoring After Gowning
The efficacy of gowning should not be verified just through the monitoring of the sequence of gowning in question. Monitoring personnel offers further proof of the effectiveness of the contamination control system.Monitoring may involve:
- Fingerprints on gloves
- Contamination plates
- Sleeves
- Any other locations essential for microbiological control
- Monitoring of particles too
Gowning Errors Commonly Observed
There are some practices that may seem insignificant but can lead to terrible contamination.Here are a few common of these practices:
- Touching sterile clothing with unclean hands
- Mistakes while putting on gloves
- Exposed hair
- Wrongly positioned face masks
- Garments touching the floor
- Mixing of clean and dirty areas incorrectly
- Moving too much while dressing
- Touching doors after dressing
- Too much fiddling with the hood, mask or goggles
- Not having good hand hygiene
Gowning and the Contamination Control Strategy
The gowning should be part of the Contamination Control Strategy (CCS) of this facility.The CCS will include the following aspects:
- Movement of people
- Gowning of personnel
- Design of a cleanroom
- Air flow
- Cleaning and disinfection
- Environmental monitoring
- Transfer of materials
- Transfer of equipment
- People qualification
- Barrier methods
- Aseptic procedures
How to Improve Gowning Practices
There are several improvements that can help make gowning practices much better.Use visual guides: Visual guides (pictures or drawings) will be superior to long explanations in many cases.
Avoid mixing clean and dirty tasks: Changing rooms must be designed in a way that the personnel should know exactly where to go.
Restrict the necessity of requalification: Gowning must be considered not as a single procedure.
Record employee supervision: If gowning is regularly disregarded, it means that the procedure needs to be improved.
Evaluate the process after any changes: After any changes are done, a gowning check must also be done.
Gowning is an important part of contamination control in sterile production, but the success of gowning does not rely solely on the garment being worn. Rather, several factors need to be considered such as the order in which the gowning steps are executed, the way the garments are handled, how people move in and out of the gowning area, the practices followed in washing hands, etc.
The best gowning program will recognize that personnel are an indispensable part of contamination control. It will therefore provide training that leads to the certification of personnel, routine monitoring and supervision. By having an understanding of the contamination risk involved in the gowning actions, personnel can be expected to observe the gowning requirements better.
One important practical tip is that the final gowning action should allow personnel access to the sterile area without excessively touching themselves, their equipment, doors or any potentially contaminated surfaces.
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