PURPOSE

To monitor viable organisms on the gloves hands, forearms and uniforms of aseptic filling room personnel.

SCOPE

This procedure applies to the aseptic filling room personnel monitoring at the applicable plant.

RESPONSIBILITY

It is the responsibility of the Microbiology Department to conduct this SOP as written.

FREQUENCY

At the beginning and at the end of aseptic filling of every production run (lot), gloved hands of all employees engaged in filling shall be monitored.

Uniforms and forearms shall be monitored once a week.

MATERIALS REQUIRED

Sterile blood agar plates or sterile TSA plates, marker, masking tape, Rodac plates and 70% isopropyl alcohol (sterile filtered).

A. THE PROCEDURE

1. Take two sterile blood agar plates or TSA plates; put them on a clean surface. Check the plates (without opening) for any contamination. Do not use if the plates show any contamination. Send all contaminated plates to Microbiology Department for discarding.

2. Aseptically, without spraying your gloves hands with 70% isopropyl alcohol or any other disinfectant, take the lid off from one of the plates.

3. Gently press five-finger tips of one hand (right or left) against the sterile medium in the plate. The pressing should be hard enough to leave visible finger impressions, yet gentle enough not to spoil the smooth agar surface.

4. Repeat step 3 for the other (second) hand.

5. Label each plate with the name of the person whose finger impressions are on the plate, product lot no., which is going to be filled or was filled, start fill or end fill and date. Sanitize hands with 70% isopropyl alcohol.

6. At the end of the production, send all plates to Microbiology Department for incubation.

7. Incubate all plates at 30-35°C for a minimum of 48 hours, along with a negative and a positive control. Prepare a positive control by streaking a plate with the viable culture of Staphylococcus aureus.

8. After incubation, record results on appropriate form (See appropriate form).

Alert Limit:1 CFU per plate

Action Limit:2 CFU per plate

B. Weekly Uniforms and Personnel Monitoring

Uniforms and forearms of all employees engaged in aseptic filling shall be checked for viable organisms by using sterile Rodac contact plates during environmental monitoring of aseptic filling area/rooms. At least one chest print from the center of the chest and one forearm print from each forearm shall be taken.

Handprints of aseptic filling room personnel shall also be taken once a week by microbiology personnel during environmental monitoring.

All plates shall be incubated at 30-35°C for a minimum of 48 hours, along with negative and positive controls. Results shall be recorded on appropriate form (See appropriate form).

Alert Limit:1 CFU/Chest/Arm Print

Action Limit:2 CFU/Chest/Arm Print

C. Weekly Aseptic Personnel Monitoring Upon Exiting Class 10,000 Area

Once a week on one randomly selected day, (e.g. Monday or Tuesday, etc.) uniforms, forearms and handprints shall be checked for viable organisms from all personnel (Manufacturing, Maintenance, Quality Assurance, Microbiology) exiting Class 10,000 area by using sterile Rodac contact plates. At least one chest print from the center of the chest and one forearm and hand from each arm shall be taken. The test shall be performed by either microbiology or production personnel.

All plates shall be incubated at 30-35°C for a minimum of 48 hours, along with positive and negative control. Results shall be recorded on appropriate form.

Limit: develop based upon data.

VIII: ACTION:

1. Whenever the count of a filling room employee exceeds the alert limit two consecutive times, the employee shall be retrained for gowning, aseptic technique and CGMPS by the Quality Assurance Department.

2. Whenever the count exceeds the action limit, additional sterility test shall be performed on the product that was filled on that day.