The process of wearing special garments in order to control particulate contamination is called Gowning.

Gowning qualification consist four stages.

Stage 1 is Initial Training and Education, which includes classroom training session.

Appropriate training should be conducted before an individual is permitted to enter the aseptic manufacturing area. Fundamental training topics should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety hazards posed by a non-sterile drug product, and the specific written procedures covering aseptic manufacturing area operations. After initial training, personnel should participate regularly in an ongoing training program.

Stage 2 is Gowning Training, Practice, and Observation.

During this stage, the trainee is taught gowning techniques and glove sanitization in a safe noncritical area. Proper techniques begin with good hygiene. In this training stage, the employee should have already removed any makeup and jewelry, placed on a hairnet (or bouffant), 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. Once the employee is “ready” to gown for the Grade B area, a top-down gowning approach is typically used. Sometimes, a second hair cover is placed on the head. Gloved hands should be sanitized prior to beginning the gowning process. Depending on the company, the face mask can be placed on before or after the sterile hood.

Stage 3 is the 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. Guidance on where to sample personnel is vague, but multiple documents emphasize gloved fingers. The guidance documents stress that sampling sites should be justified. Sites that are often sampled include gloved fingers, forearms, chest, shoulders, thighs, hoods, and boots. Some companies include the face mask.

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.