ASEPTIC GOWNING QUALIFICATION PROGRAM

  By: Sachin Kumar Sharma  

Senior Executive: Quality Assurance
Celogen Lanka, Pvt. Ltd.

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 ASEPTIC GOWNING QUALIFICATION PROGRAM

Introduction
❖ Pharmaceutical safety is crucial to protect patients from contamination and ensure product
efficacy. Sterile gowning procedures play a vital role in maintaining a sterile environment during
pharmaceutical manufacturing. This presentation will provide an overview of the key steps involved
in sterile gowning procedures, Gowning qualifications and highlight their importance in
pharmaceutical safety.
❖ The primary purpose of cleanroom gowning is to protect the product and the environment
from microbial contamination. When used correctly, cleanroom gowning greatly reduces the
microorganisms released by personnel.
❖ All personnel are required to be properly trained & gowned before entering the cleanrooms.

❖ Proper training, education, hygiene, qualification, and authorization is required to

enter into clean rooms.

Regulatory Requirement:
❖ Strict Regulatory guidelines govern sterile gowning procedure to maintain product quality.
These guidelines outline the use of clean room attire, including sterile gowns, gloves and
masks.
❖ Adherence to these guidelines is essential to prevent microbial contamination and ensure
the safety of pharmaceutical products.

Clean Room Environment:

❖ A cleanroom environment is essential for sterile gowning procedure. It features controlled air
quality; low particle counts and strict cleaning protocols.
❖ Regular cleaning and maintenance of the clean room minimize the risk of contamination and ensure
the integrity of pharmaceutical Product.

Personnel Hygiene:
❖ Personnel must maintain good hygiene. This encompasses taking a daily shower to reduce skin
shedding, frequently washing one’s hair removing jewelry and makeup, proper handwashing prior
to gowning and keeping on open line of communication with management regarding
sickness and compromised skin conditions.
❖ Sick employees or one’s with compromised skin (such as fresh tattoos or sunburn) should not enter
the cleanroom.

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 Quality of Clean Room Gowns:
❖ There are many different gowning supplies available in the market and material may vary.
❖ Gowning components may be purchased either as sterile for one time use or in reusable form.
❖ Reusable gowns must be managed to ensure the integrity of the garment is maintained through
multiple washing and sterilization cycles. Both the washing and sterilization process must be
validated. There are pharmaceutical laundry services that can manage these activities.
❖ Scrubs must cover as much skin as possible.
❖ Scrubs and cleanroom gowning supplies (face mask, hoods, protective goggles, gloves coveralls
and boots/booties) should be sterile and made of non-particle shedding material.
❖ During gowning, personnel should take care to follow aseptic gowning practices.
❖ This includes
✓ Gowning from the top to down
✓ Wearing sterile non powdered gloves and not touching the outside of the sterile gown
✓ The Gown should not touch the floor while gowning
✓ After gowning, no skin or hair should be exposed.

Gowning Steps:
❖ Proper gowning involves several key steps, including hand hygiene, donning sterile gloves, wearing
a sterile gown. and using appropriate disinfectants. Each step is designed to minimize the risk of
microbial contamination and maintain a sterile environment throughout the pharmaceutical
manufacturing process.

Gowning Qualification:
❖ Aseptic Gowning Qualification program ensure the ability of personnel to maintain the quality of the
gown after gowning.

Step-1: Training and Education

❖ Initial training and education, which includes classroom training sessions.
❖ Training topics should include aseptic techniques, cleanroom behavior, microbiology, hygiene,
gowning, aseptic practices and the specific written procedure covering aseptic manufacturing area
operations.
The 2004 FDA Guidance for the industry on sterile drug products produced by aseptic
processing- current good manufacturing practices states “Appropriate training should be
conducted before an individual is permitted to enter the aseptic manufacturing area”
EU GMP Annexure-1 States that “All personnel (including those concerned with cleaning and
maintenance) employed in such areas should receive regular training in disciplines relevant
to the correct manufacture of sterile products.
❖ This training should include reference to hygiene and to the basic elements of microbiology.

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 Step-2: Gowning Demonstration, Practice and Observation
❖ During this stage, the trainee is taught gowning technique and glove sanitization in a safe non critical
area, such as training hall or conference room.
❖ Proper techniques begin with good hygiene.
❖ In this training stage, the employee should have already removed any makeup and jewelry, placed
on a hairnet, properly washed their hands, donned sterile scrubs with care, donned shoe covers and
be properly gowned to be in a Grade-C Area according to the site procedure.
❖ The Trainee is allowed to practice these gowning steps in a safe, non-critical environment under the
observation of a qualified trainer.
❖ When both the trainee and trainer feel comfortable with the trainee’s gowning technique, Step 3 may
begin.

Step-2: Qualification to enter Grade B area

❖ During stage 3, general growth media contact plates are utilized to analyze whether the trainee
gowned correctly without contaminating the sterile outer gown, sterile gloves and sterile head cover.
❖ The employee is observed gowning and the gowning components are sampled in several areas with
the contact plates to determine the level of microbial contamination on the gowns.
❖ The trainee must undergo three successive gowning processes and be evaluated through
microbiological sampling.
❖ The sampling sites should be justified. Sites that are often sampled include gloved fingers, forearms,
chest, arm pits, hoods, and boots.
❖ Some companies include the face mask. If the face mask is monitored, the justification for analyzing
the site should include recognition that the face mask is not a total barrier against microorganisms.
❖ Operators should be properly trained not to shout or talk excessively while gowning or while properly
gowned in the cleanroom area.
❖ Note that passing stages 1 through 3 only qualifies an employee’s ability to gown into a Grade B
area. Personnel should not assist with Grade A activities until they participate in a media fill.

Personnel Monitoring in Cleanroom

❖ Personnel in critical areas may be monitored for microbial contamination utilizing contact plates. The
contact plates monitor areas of the body that may interact with the sterile field or product exposure
areas. These may include gloved hands, forearms, or other areas.
❖ Personnel monitoring is performed to ensure the maintenance of the sterile environment. The majority
of contamination within a facility can be traced to humans working in cleanrooms. Specific procedures
for gowning and sterilizing, need to be followed by the personnel before entering and exiting the aseptic
cleanroom.

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❖ Personnel monitoring aims at determining airborne contaminants in the employee breathing zone (EBZ),
which is assumed to be the amount actually inhaled. The two most popular methods that have been
used for EO exposure determination are charcoal tubes and passive dosimeters.
❖ Personnel monitoring is a good indication of how well personnel are gowning when they enter the clean
room. Many companies utilize this testing for proficiency-based training programs for clean room
personnel.
❖ Whenever personnel monitoring samples required?
➢ If that person entered into the aseptic area during filling activity
➢ After completion of aseptic activity (Aseptic connection, Filling, Sealing, Filtration)
➢ After perform Area monitoring and Environmental monitoring)
➢ During filling machine breakdown after rectified engaged Engineering person exit time
Aseptic activity engaged and Supporting activity persons being whenever (Each shift) exit from
the Aseptic area
➢ During filling activity Other than All Applicable gowned donned personnel if anyone entry into the
aseptic area.

Personnel Sampling locations:

Location ID. Sampling Location Recommended Method for sampling
L-1 Headgear - Forehead Contact Plate
L-2 Headgear - back of Head Contact Plate
L-3 Middle of the Chest Contact Plate
L-4 Shoulder - Left Contact Plate
L-5 Shoulder - Right Contact Plate
L-6 Armpit - Left Contact Plate
L-7 Armpit - Right Contact Plate
L-8 Elbow - Left Contact Plate
L-9 Elbow - Right Contact Plate
L - 10 Belly Contact Plate
L - 11 Forearm - Left Contact Plate
L - 12 Forearm - Right Contact Plate
L - 13 Finger dab - Left Contact Plate
L - 14 Finger dab - Right Contact Plate
L - 15 Goggles - Left Cotton Swab
L - 16 Goggles - Right Cotton Swab
L - 17 Booties - Left Contact Plate
L - 18 Booties - Right Contact Plate

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PICTORIAL PRESENTATION OF SAMPLING LOCATIONS FOR PERSONNEL MONITORING

L- 2 “Headgear” Back to head

L- 1 “Headgear” Forehead

L- 15 “Goggles - Left” L- 16 Goggles-Right”

L- 4 “Shoulder - Left” L- 5 “Shoulder - Right”

L- 3
L- 6 “Armpit - Left” “Middle of the Chest”

L- 7“Armpit - Right”

L- 8 “Elbow - Left”
L- 9 “Elbow - Right”

L- 10 “Belly”
L - 12 “Forearm - Right”

L-11 “Forearm - Left”

L - 14 “Finger Dab-Right”
L – 13 “Finger Dab-Left”

L- 17 “Booties - Left” L- 18 “Booties - Right”

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 ❖ Required Media for Sampling:
➢ Gloved hand finger dab (SCDA 90mm)
➢ Personnel gowns (RODAC Contact plates 55mm)
➢ Sterile gowning Zip (0.9% Sterile saline swab)

❖ Sampling performed depend upon the Aseptic activity

Grade A: Extended Filling zone LAF (Aseptic filling activity & other supporting aseptic activity of
critical area)
Grade A&B: Under LAF, Buffer room, Corridor

❖ Incubation conditions:
20-25°C for 72 hours followed by 30-35°C for 48 hrs.

❖ Acceptance criteria:
Grade A:<1 CFU
Grade B:<5 CFU

❖ Note:
➢ Before Entry into the Aseptic area, personnel gowning qualification is required
➢ Personnel before involved into the Critical operation of aseptic activity assessment, adequate
job training and Operator aseptic activity evaluation is mandatory.
➢ Personnel Gowning qualification &Operator Aseptic Evaluation done 3 consecutive days.

Step-4: Maintenance:
❖ Stage 4 consists of program maintenance, routine monitoring, requalification, and disqualifications,
when warranted.
❖ Requalification may include participation in educational refresher courses, a single successful
gowning qualification, and an annual participation in a successful media fill (as applicable).
❖ In order to protect the environment and the product, the integrity of the cleanroom gown must be
maintained.
❖ This is partly accomplished through thorough training and education of the employees.

Conclusion:
❖ Sterile gowning procedures are indispensable for ensuring pharmaceutical safety.
❖ Adhering to regulatory guidelines, following proper gowning steps, maintaining a cleanroom
environment, and providing adequate training are key to preventing contamination and safeguarding
the integrity of pharmaceutical products.

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 References
1. Guidance for Industry (2004), Sterile Drug Products Produced by Aseptic Processing- Current
Good Manufacturing Practice. Pharmaceutical cGMPs. Accessed on October 30, 2022
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-
products-produced-aseptic-processing-current-good-manufacturing-practice
2. Annex 1 (2022), The Rules Governing Medicinal Products in the European Union- EU Guidelines
to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. Annex 1-
Manufacture of Sterile Medicinal Products. European Commission EudraLex, 4.
3. United States Pharmacopeia (USP) <1116> Microbiological Evaluation of Cleanrooms and Other
Controlled Environments.
4. Brandes, R. (2012), Aseptic Processing: Qualification of Personnel. GMP Publishing, 12. Accessed
on October 30, 2022 at: https://www.gmp-verlag.de/content/en/gmp-news/gmp-newsletter/gmp-
logfile-lead-article/d/1215/qualification-personnel-aseptic-processing-gmp-logfile
5. FDA Manual (2015), Food and Drug Administration Compliance Program Guidance Manual
Chapter 56- Drug Quality Assurance. Sterile Drug Process Inspections, Program 7356.002A,
Accessed on October 31, 2022, at https://www.fda.gov/media/75174/download
6. PDA (2022), PDA Technical Report No. 13- Revised 2022: Fundamentals of an Environmental
Monitoring Program. PDA, Bethesda, MD.
7. Hayes, B. (2015) Managing Aseptic Gowning within Classified Environments. Clean Room
Technology, 3. Accessed on October 30, 2022,
at: https://cleanroomtechnology.com/news/article_page/Managing_aseptic_gowning_within_class
ified environments/107339
8. Pharmaceutical Microbiology Manual (2020), Pharmaceutical Microbiology Manual, Version 02,
ORA. 007, 25Aug2020. Accessed on October 30, 2022,
at https://www.fda.gov/media/88801/download

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