Health & Cleanliness of Personnel Working in an Aseptic Area | Standard Operating Procedure

The Standard Operating Procedure (SOP) for the Health & Cleanliness of Personnel Working in an Aseptic Area is as below:

Purpose

To define the procedure to be followed for proper Hygiene & Cleanliness of personnel working in an aseptic area.

Scope

This SOP applies to ensure the health & cleanliness of personnel working in aseptic areas to avoid microbiological contamination & bioburden.

Definition

None.

Responsibility

Routine responsibility for ensuring that this procedure is implemented as & when necessary rests with the following personnel:

  1. Deputy Production Manager
  2. 2. Officers (Sterile)
  3. Supervisor (Sterile)

Method

  • Only the minimum number of personnel required should be present in a clean area.
  • High standards of personal hygiene & cleanliness are essential & personnel involved in the manufacture of sterile preparation should report any condition that may cause the shedding of abnormal numbers or types of contaminates.
  • The health & cleanliness condition of all persons is to be checked by a designated person before entering the aseptic area & should be recorded.
  • The health conditions of personnel working in an aseptic area should be checked once in three months.

Health

  • Personnel with open wounds, rashes, boils, or any other skin ailment must not be permitted to work in clean & aseptic areas.
  • Personnel suffering from upper respiratory tract infections, colds, coughs, fever, etc must not be allowed to work in clean & aseptic areas.

Personal Cleanliness

  • Nails of persons working in clean & aseptic areas should be regularly trimmed.
  • Personnel should be encouraged to keep their hair short to minimize the hazards of contamination through hair.
  • Jewellery & unnecessary cosmetics should not be allowed in sterile manufacturing areas.
  • Attitudes toward cleanliness should be instilled in personnel by training in basic elements of microbiology.
  • The number of persons working in an aseptic area should be kept to the minimum practicable.
  • Personnel should not move about unnecessarily in an aseptic area because movement increases particulate & bacterial shedding.
  • Persons engaged in maintenance work or process adjustments or rectification of minor faults to equipment must observe the same precautions & hygienic standards as production personnel.

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