Cleanroom Gowning Procedures: Best Practices for Grade A/B Areas

In 2022, a sterile manufacturing facility in North America issued a voluntary recall for over 100,000 units of injectable vials. The cause? Microbial contamination traced back to an operator who had improperly donned sterile gloves in a Grade A filling suite. This lapse in cleanroom gowning procedures seemed minor—but the consequence was monumental.

This isn’t an isolated case. Personnel are the largest source of cleanroom contamination, especially in Grade A and B areas. That’s why gowning protocols aren’t just guidelines—they’re frontline defenses against contamination control. In this guide, we explore how to get gowning right every time in the most critical cleanroom environments, ensuring strict cleanroom compliance and adherence to aseptic practices.

Understanding the importance of proper sterile gloves donning and the correct use of coveralls and other garments like beard snoods is essential for maintaining an aseptic position in cleanrooms.



Why Gowning Matters in Pharma Cleanrooms

In the biotechnology industry, proper gowning in pharma cleanrooms is essential for maintaining ISO 5 conditions. Personnel shed approximately 100,000 particles per minute just by standing still. Without effective Grade A/B gowning, these particles—including skin flakes, microbes, and fibers—can compromise sterile areas and hinder contamination prevention efforts.

Gowning objectives:

• Prevent contamination from operators to product/environment
• Maintain ISO 5 / Grade A conditions
• Support GMP requirements, Annex 1 compliance, and FDA standards

Grade A/B gowning must be consistent, validated, and behaviorally reinforced. It’s important to consider the features of cleanroom garments for contamination prevention, such as using boots and reusable garments designed specifically for this purpose. Additionally, effective gowning system management is crucial to ensure adherence to guidance on cleanroom gowning sequences and protocols.

By understanding the importance of cleanroom particle control and adhering to these standards, pharmaceutical companies can protect the integrity of their products and ensure a safe working environment.

Key Cleanroom Zones in Gowning Workflow

Each transition between these cleanroom zones requires strict protocol adherence to prevent backflow contamination and ensure the integrity of the gowning workflow. The importance of training and re-training for gowning procedures cannot be overstated, as proper techniques like custom folding of cleanroom gowns for efficiency are essential in cleantech manufacturing environments.

Additionally, following a top-bottom sequence gowning approach helps minimize the risk of introducing microorganisms into controlled areas.

Step-by-Step Sterile Gowning Procedure (Grade A/B)

1. Pre-Gowning Hygiene

• Remove jewelry, makeup, and watches
• Wash hands for at least 30 seconds with antimicrobial soap; ensure thorough antimicrobial soap handwashing to maintain personal hygiene cleanroom standards.
• Dry hands using a HEPA-filtered air dryer or sterile wipes

2. Don Cleanroom Garments (Outside Gowning Area)

• Hair cover/cap
• Beard/moustache cover (if applicable)
• Inner disposable gloves
• Cleanroom undersuit (if required)

3. Enter Grade B Gowning Room

• Step over bench separating zones
• Sanitize hands with sterile IPA

4. Don Sterile Garments (Inside Gowning Room)

• Employ the sterile coverall technique: put on the sterile coverall (zip up completely, avoid touching external surfaces)
• Sterile boots or shoe covers (worn while seated, one foot at a time)
• Sterile hood (tuck under coverall collar); consider packaging of hoods and masks together for ease of use.
• Sterile goggles (disinfect with sterile IPA)
• Outer sterile gloves (over sleeve cuffs, secure with adhesive tape)

5. Final Check

• Inspect for tears, misalignment, or improper closure
• Sanitize outer gloves before entry to Grade A area; this is crucial during the Grade B to Grade A transition.

Additional Notes on Aseptic Gowning:

When following cleanroom gowning procedures, always be mindful of preventing contamination through correct gowning techniques. Ensure that the gowning room maintains ISO Class 5 environment standards to guarantee sterility. Additionally, explore how custom folding and packaging can enhance gowning efficiency and reduce contamination risk during the entire process.

Gowning Do’s and Don’ts

Do:

• Follow gowning sequence adherence by strictly adhering to the donning sequence
• Change gloves if contaminated, following the contaminated gloves protocol
• Keep gowning pace calm and deliberate to ensure gowning pace control
• Use mirrors to check gown integrity inspection and ensure the gown's proper condition

Don’t:

• Touch face or mouth mask during gowning to understand the importance of cleanroom gowning to prevent contamination
• Adjust gown mid-procedure, as this can disrupt cleanroom training compliance
• Talk unnecessarily
• Enter without gowning validation requirements or proper cleanroom garments training

Before entering the gownroom, ensure that you have completed hand washing and disinfecting procedures and are wearing a hairnet.

Training and Qualification

Gowning proficiency assessment must be:

• Assessed visually during qualification
• Retested annually or after deviation as part of annual requalification
• Recorded in the personnel qualification file

Training should include:

• Classroom instruction for gowning
• Gowning simulations training
• Contamination control behavior education
• Microbial monitoring post-gowning

Ensure that training covers the requirements for aseptic gowning in Grade A and B cleanrooms, including the proper use of beard covers, scrubs, and shoe covers. Participants should learn detailed steps for proper cleanroom gowning procedure adherence, such as wearing boots and following the gowning procedure meticulously.

💡 Tip: Use fluorescent powder or settle plates to show gowning errors during training.

Additionally, implement regular gowning training and re-training sessions to maintain high standards of cleanliness and contamination control.

Monitoring Gowning Effectiveness in Cleanroom Environments

1. Personnel Monitoring (PM) in Gowning

• Use contact plates for microbial limits on gloves, forearms, and chest post-gowning
• Ensure compliance with microbial limits defined for Grade A/B zones
• Incorporate best practices for pre-gowing hygiene and preparation in controlled environments

2. EM Trend Review in Cleanrooms

• Correlate personnel EM data with batch sterility outcomes
• Track operator-wise data for recurring issues

3. Gown Integrity Checks and SOP Review

• Conduct daily visual inspections of gowns, frocks, and smocks
• Perform monthly SOP reviews for gown requalification, including inspection and maintenance of cleanroom garment integrity and sterility
• Ensure the use of disposable caps and cleanroom goggles as part of standard cleanroom gowning procedures

Gowning Materials and Selection

Single-Use vs Reusable Gowns

• Single-use gowns: Offer better sterility assurance in gowning materials, reduce the risk of cross-contamination, and eliminate the need for laundering.
• Reusable gowns: While cost-effective long-term, they require validated laundering for reusable garments and careful tracking to ensure continued sterility.

Material Requirements:

• Low-linting cleanroom fabrics that are non-shedding
• Sterile options such as gamma-irradiated sterile coveralls
• Breathable materials that resist contamination

Typical Garments:

• Sterile coveralls
• Cleanroom boots
• Goggles (autoclavable or single-use)
• Sterile nitrile gloves
• Hoods and face masks
• Cleanroom mats for maintaining hygiene

Identifying Types of Garments Used in Cleanrooms and Their Correct Usage Order:

• Begin with the hood to contain hair and prevent contamination.
• Don the mask to ensure respiratory protection.
• Put on sterile nitrile gloves, ensuring they are free from defects.
• Wear the sterile coveralls, making sure they fit properly and cover all skin.
• Finally, use cleanroom boots to protect against particulate ingress.

Additional Considerations:

• Always perform an inspection of garment packaging and sterilisation indicators before use.
• Refer to ISO 14644 Annex B for guidelines on cleanroom classification and gowning procedures.
• Utilize a gowning checklist to ensure compliance with all protocols.

Common Gowning Mistakes in Grade A/B Areas

• Wearing gowns inside out or unzipped, which can lead to contamination risks in the gowning process
• Failing to tape gloves over sleeves and ensure proper seal with tunneled elastic cuffs
• Sitting on cleanroom benches post-gowning, violating personnel hygiene protocols
• Using expired sterile garments or improper gown usage errors like neglecting boot covers
• Rushing through the gowning process and skipping essential steps like donning sterile cleanroom garments steps
• Disregarding undergarments that are suitable for cleanroom environments

Be sure to discover features that improve ease and effectiveness of aseptic gowning garments and accessories, such as coil zippers and socket snap adjustments.

Case Study: Operator Hygiene Saves a Sterile Batch

A biosimilar plant in Hyderabad conducted a microbial spike investigation after detecting a contamination issue in Grade B EM. The root cause analysis (RCA) pointed to glove contamination during cleanroom gowning procedures, specifically noting that the operator’s glove touched the gown exterior before taping.

To address this issue, the corrective and preventive actions (CAPA) included comprehensive gowning retraining strategies. This training emphasized pre-gowning hygiene practices such as shower washing, hair and makeup removal, and thorough hand washing. Additionally, the facility implemented visual SOP posters to reinforce proper donning techniques and revised the use of gowning mirrors.

To further enhance cleanroom contamination control, the plant introduced glove packaging wallets and ensured that all operators wore goggles as part of their facility suit. Since these measures were implemented, no excursions have been reported in over 18 months, demonstrating the effectiveness of stringent sterile gowning protocols and awareness of cleanroom contamination control mats.

Conclusion:

In pharmaceutical cleanrooms, compliance isn’t just about facility design—it lives in everyday behaviors. Proper gowning is the clearest expression of GMP culture in cleanrooms.

A cleanroom is only as sterile as its people are disciplined. In Grade A/B zones, that sterility discipline begins with the first glove and ends with the last sanitizing spray. Following cleanroom gowning procedures steps is essential; adhere to protocol not just because the SOP says so—but because your product, your patient, and your profession depend on it.

Understanding the importance of gowning in cleanrooms is crucial for maintaining compliance in gowning procedures. Each step, from donning cleanroom apparel order and technique to implementing the double gloving technique in cleanrooms, ensures that contamination risks are minimized.

Moreover, using dedicated footwear and appropriate PPE (Personal Protective Equipment) like masks is vital in upholding the standards set by cleanroom classifications ISO standards. Remember that aftercare in cleanroom gowning procedures is just as important—properly removing and storing garments helps maintain the integrity of the sterile environment.

FAQs:

Q1. What is the cleanroom gowning qualification frequency for operators?

Cleanroom operators should be gowning qualified at least once a year, or after any major deviation or process change.

Q2. Should daily gowning monitoring practices be implemented?

Yes, routine personnel monitoring should be part of your EM program in ISO 5 cleanroom operations, especially in Grade A/B settings.

Q3. What are the key zones involved in the sterile gowning process?

The key gowning zones include the Gowning Stage (no specific grade), First Change Room (Grade D/C), Gowning Airlock (Grade B), and the Final Prep Zone where Grade A access is granted. Strict adherence to protocols during transitions between these zones prevents backflow contamination.

Q4. What are the main dos and don'ts during sterile gowning in Grade A/B areas?

Do follow the gowning sequence strictly, change contaminated gloves immediately, maintain a calm and deliberate pace, and use mirrors to check gown integrity. Don't touch your face or mask during gowning, adjust gowns mid-procedure, talk unnecessarily, or enter cleanrooms without proper validation and training.