| Department | Micro Laboratory | Document no | MICLAB 010 | ||
| Title | Validation of Aseptic Gowning Procedures | ||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Microbiology Laboratory Manager
Affected Parties
All Validation and Microbiology Laboratory colleagues
Purpose
Aseptic gowning is the ability to complete the gowning procedure without compromising the sterility of the garment. This SOP outlines the sterile gowning validation procedure as required for the final sign off for the initial sterile training and the revalidation of currently trained Operators, Fitters, Electricians and Cleaners and all organization staff who are authorized to enter Sterile areas.
Responsibilities
Each Functional Area Manager is responsible for ensuring that all staff who are required to enter Sterile areas have successfully demonstrated their gowning competency through passing their gowning validation.
The Microbiology Laboratory staffs are responsible for carrying out the review of the gowning competency and assessing the results.
The Training department is responsible for recording and storing (filing) the results in the individuals training files and keeping the individuals/teams updated with this information.
The Training Department is responsible for the scheduling and booking of all sterile training and retraining sessions.
Definition
| cfu | Colony Forming Unit representing one micro-organism |
| Aseptic | Free from contamination |
| Contact plates | Sterile dish of microbiological media used to monitor surfaces such as sterile gowns |
Related Documents
| MICLAB 005 | Entry Procedure of Sterile Filling Area |
| Form 655 | Validation Record For Sterile Gowning Procedure |
EHS Statement
Safety glasses and gloves must be worn when using IPA.
Personnel who are ill, e.g. with a cold, flu symptoms, stomach disorder, open lesions, any type of skin disorder such as sunburn must check with their Process Manager / Microlab Department before they can enter the sterile areas.
Procedure
1. Introduction
1.1. New personnel who will be routinely entering the sterile area will attend the Sterile Training sessions conducted by the company training department with the microbiology team. When fully competent in the entry/exit procedures for the sterile area as outlined in MICLAB 005 the operator will be validated following the procedure outlined in this SOP.
1.2. Revalidation should be carried out annually within 1 months of completing the sterile retraining sessions.
1.3. Gowning validations assessments will be carried out in the Sterile Scrub Preparation room.
1.4. No more than two people can be validated in any one Sterile Scrub Preparation room at the same time.
2. Method of Initial Validation
2.1. After the sterile training session the candidate will complete a full gowning session in the Sterile Scrub Preparation room. He/she will be observed by a fully trained and validated Microbiologist and assessed according to the Checklist for Procedure for Entry into Sterile (Form 655). This should occur within 1month of training. It is the individual’s responsibility to book their own sterile gowning validation session with the Microbiology Department.
2.2. If the scrub and gowning procedure requirement is met according to the checklist then the validation procedure may be conducted.
2.3. On completion of the full gowning procedure the candidate will perform a finger dab plate. Six (6) contact plates will be used to assess the ability of the candidate to maintain the sterility of the uniform during the sterile gowning procedure.
2.4. The Microbiology Lab observer will conduct the monitoring wearing sterile gloves, in order to prevent any possible contamination on the outside of the plates being transferred to the person being monitored.
3. Areas of the gown to be monitored at validation
a. Gloves (without the addition of Hexifoam).
b. Gown sleeves (at cuff)
c. Gown chest (at zipper top)
d. Hood (near forehead)
e. Hood (side or back)
f. Gown (at top of overshoes at knee)
g. Overshoes (at top of foot)
3.1. At the time of the Validation session, the Microbiology Laboratory observer will label all plates with the candidate’s name, area monitored and the date.
3.2. The plates will then be brought to the Microbiology Laboratory together with Form 655 for incubation at 32°C for 48 hours. The plates will be then transferred into the 25°C for 72 hours. After the incubation the results will be read and recorded in the registrar book. The form is to be signed by the Microbiology Laboratory observer and photocopied and the copy sent to Training Dept. for filing in the Operator’s Training File. The original document will be kept in the Microbiology Laboratory Validated Sterile Operators folder.
The individual should not enter the sterile area until a gowning validation has been successfully completed.
3.3. Individuals will be notified with their results and copied to their Process Manager. Successful trainee should be grant access to the sterile areas.
4.1. Annual re-validation is required for all validated personnel and will consist of the sterile re-training sessions followed by the aseptic gowning procedure validation. For personnel being retrained a Re-validation needs to be completed within 1 month.
4.2. The re-validation procedure is the same as the procedure outlined in Section 3
5.1. The acceptance criteria are less than or equal to 1 cfu per plate for finger dabs and no more than a total of 3 cfus / set of 6 contact plates or per single contact plate.
5.2. If the acceptance criteria are not met then a second validation is permitted. In this event notification will be sent to the Process Manager and the individual concerned.
6. Actions in the Event of a Failure
6.1. In the event of a failure the Microbiology Laboratory will inform the relevant individual concerned and their Process Manager to ensure follow up steps are appropriate. This may include counselling or re-training if deemed necessary.
6.2. The objective of the counselling session is to:
6.2.1. Highlight the results to the operator.
6.2.2. Discuss potential causes; provide advice to help prevent recurrence.
6.2.3. Outline the remedial action, which will be taken.
7. Remedial Actions Initial Validation (After Full Sterile Training)
7.1. In the event of a failure of the initial validation a re-validation is permitted.
7.2. In the event of a second failure (after advice to prevent recurrence) the individual is permitted a third attempt.
7.3. Following a failure upon the third attempt, the individual will have a discussion session with the Microbiology Sterile Trainer to review the individual’s understanding and discuss potential causes and provide advice. A determination of whether there is a medical problem that may need treatment may also be appropriate.
7.4. A fourth attempt will be permitted, only after the discussion session.
7.5. If this fourth attempt fails, the individual fails to meet the acceptance criteria and he/she will be deemed as not suitable for working or entering into the aseptic suites.
8. Remedial Actions Annual Re-Validation or after absence from the Area (after Sterile Re-Training)
8.1. In the event of a failure of the initial annual validation a re-validation is permitted as outlined in Section 7
| Version # | Revision History |
| MICLAB 010 | New |