This document discusses the importance of aseptic gowning procedures for maintaining sterile environments during pharmaceutical manufacturing. It outlines the key steps in sterile gowning which include regulatory requirements, cleanroom environments, personnel hygiene, gown materials, and proper gowning techniques. The document also describes the various steps involved in a gowning qualification program to ensure personnel can properly gown without contamination risks. These steps include training, demonstration and observation, qualification trials, and ongoing maintenance and monitoring. Adherence to sterile gowning procedures and qualification programs is essential for preventing microbial contamination and ensuring pharmaceutical product safety.

1. Aseptic Gowning
Qualification
Program
Sridhar Devu
devusreedhar@gmail.com

2. 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 Qualification
and highlight their importance in ensuring
pharmaceutical safety.

3. 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 and gowned before entering the
cleanrooms.
Proper training, education, hygiene,
qualification, and authorization is
required to enter into clean rooms.

4. Regulatory
requirements
Strict regulatory guidelines govern
sterile gowning procedures to maintain
product quality. These guidelines outline
the use of cleanroom attire, including
sterile gowns, gloves, and masks.
Adherence to these guidelines is
essential to prevent microbial
contamination and ensure the safety of
pharmaceutical products.

5. Clean room
environment
A cleanroom environment is essential for
sterile gowning procedures. It features
controlled air quality, low particle counts, and
strict cleanliness protocols. Regular cleaning
and maintenance of the cleanroom minimize
the risk of contamination and ensure the
integrity of pharmaceutical products.

6. 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 an open line of
communication with management
regarding sickness and compromised skin
conditions. Sick employees or ones with
compromised skin (such as fresh tattoos or
sunburn) should not enter the cleanroom

7. Quality of clean room
gowns
There are many different gowning supplies
available on the market, and materials 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 the sterilization processes must be
validated. There are pharmaceutical laundry
services available that can manage these activities

8. Scrubs must cover as much skin as possible.
Scrubs and cleanroom gowning supplies (face
masks, hoods, protective goggles, gloves,
coveralls, and boots) should be sterile and made
of non-particle-shedding material.
When gowning, personnel should take care to
use aseptic gowning practices. These include
gowning from the top down, wearing sterile
nonpowdered gloves, and not touching the
outside of the sterile gown. The gown
should not touch to the floor while gowning.
After gowning, no skin or hair should be
exposed.
Quality of clean room
gowns

9. 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.

10. Gowning
Qualification
Aseptic gowning qualification program ensures the ability of personnel to maintain the quality of
the gown after gowning.

11. Gowning Qualification
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 procedures covering aseptic manufacturing area
operations.
The 2004 FDA Guidance for the Industry on Sterile Drug Products Produced by Aseptic
Processing - Current Good Manufacturing Practice states “Appropriate training should be
conducted before an individual is permitted to enter the aseptic manufacturing area
Annex 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.”

12. Gowning Qualification
Step:2: Gowning demonstration,
Practice, and Observation
During this stage, the trainee is taught gowning techniques and glove sanitization in
a safe noncritical area, such as a 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 site procedures. The trainee is allowed to practice these gowning steps
in a safe, noncritical environment under the observation of a qualified trainer. When
both the trainee and trainer feel comfortable with the trainee’s gowning technique,
Stage 3 may begin.

13. Gowning Qualification
Step:3: Qualification to enter Grade B areas
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 then 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.

14. Gowning Qualification
Step:3: Qualification to enter Grade B areas
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.

15. Gowning Qualification
Step:4 Maintenance and Monitoring
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.

16. 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.