Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

Document No:
Title: Page No.
SOP/SL/008
Form: None Monitoring of Personnel Hygiene Page 1 of 4

Effective Date Revision Date

Monitoring of Personnel Hygiene

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No:
Title: Page No.
SOP/SL/008
Form: None Monitoring of Personnel Hygiene Page 2 of 4

Effective Date Revision Date

The purpose is to develop a procedure for monitoring of personnel hygiene (hands, cough,
and clothes) in the production, packaging, and quality assurance staff.
2. Scope

This procedure is applicable to all of personnel in Humanwell Pharmaceutical Ethiopia

PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It is the responsibility of microbiologists to follow the procedure. Production and QA

managers are responsible for SOP compliance.

5. Material and Equipment

 Swab for testing the clothes

 TSA-filled plates (the media contain neutralizing agents for disinfectants) for testing the
hands
6. Procedure
6.1. Clothing swab

 Prepare the sterile swab with 3 ml of neutralizing solution to the applied disinfectant.
 Aseptically, take the sample from 25 cm of the clothes after work.
 Under LAF, pour 3 ml of neutralizing solution into sterile plate with 25 ml of TSA.
 Incubate for 3 to 5 days at 32°C.
 Count the number of colonies per plate.
 Identify the detected microbes, using API tests.
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No:
Title: Page No.
SOP/SL/008
Form: None Monitoring of Personnel Hygiene Page 3 of 4

Effective Date Revision Date

6.2. Fingerprint

 Prepare sterile plate contain 25 ml of TSA with neutralizing agents to the applied
disinfectant.
 Incubate for 2 days at 32°C for sterility assurance.
 Aseptically, let the staff being tested print each hand in one side of the plate.
 Mark the plate with staff name and I.D. number, date, time, and product run.
 Incubate for 3 to 5 days at 32°C.
 Count the number of colonies per plate.
 Identify the detected microbes, using API tests.

6.3. Acceptance Criteria

6.3.1. Cleaning hands

 For sterile area (class 100), the detected count for ten fingers is not more than 3
CFUs/gloves.
 For nonsterile area (class 10,000), the detected count for ten fingers is not more
than 10 CFUs/gloves.
 For nonsterile area (class 100,000), the detect count for ten fingers is not more than
50 CFUs/gloves, absence of enterobacteriaceae.

6.3.2. Cleaning clothes

 For sterile area (class 100), the detected count for 25 cm is not more than 5
CFUs/swab.
 For nonsterile area (class 10,000), the detect count for 25 cm is not more than 10
CFUs/swab.
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No:
Title: Page No.
SOP/SL/008
Form: None Monitoring of Personnel Hygiene Page 4 of 4

Effective Date Revision Date

 For nonsterile area (class 100,000), the detected count for 25 cm is not more than 50
CFUs/swab, absence of enterobacteriaceae.

6.4. Frequency

 For sterile areas (class 100), the test is performed each shift of the production run.
 For nonsterile areas (class 10,000), the test is performed once per week.
 For nonsterile areas (class 100,000), the test is performed once every 3 months.

7. Abbreviations
 SOP - Standard Operating Procedure

8. Related Documents /Applicable document/

None

9. Revision History

Version
Revision Description
No.

1 New