General Rules to be followed for Working in Injectable Area in Pharmaceuticals

Procedure to be Followed as mentioned below (but not Limited to) :

  • Before entering sterile area check temperature, humidity and differential pressures.
  • Check that the area is kept clean at all time.
  • Confirm the sterilization of sterile gowns and gloves by checking the indicators.
  • Do not reuse the dress for second entry.
  • Before touching any product container, machine parts,  disinfect the hands with suitable disinfectant
  • Use sterilized forceps to pick up the fallen vials & stoppers on the machine and turn table.
  • Avoid unnecessary movements, excessive activities, Speedy movements, and opening of the doors frequently.
  • Exit should be through return change room only.
  • At regular intervals check temperature, humidity and differential pressure.
  • For reasons of comfort and efficiency, establish a minimum number of people to be allowed in the air locks any one time.
  • No personnel articles (purses, bags, jewellery, watches etc.,) are permitted inside the sterile rooms or air locks.
  • Person with sickness should not be allowed to enter the sterile area.
  • No verbal communication should be done through the pass through box or air locks.
  • All doors of the sterile area should be checked for proper closing.
  • All materials, containers and equipment introduced into the sterile room must be subjected to sterilization and proper disinfection procedures prior to taking them in sterile areas.
  • Use lint free dusters for cleaning in sterile areas. Mops, brooms, and other customary cleaning equipment should not be used in sterile areas.
  • Paper in any form is not allowed into sterile rooms.
  • No pencils or ball pens should be used in sterile room.
  • Maintain the cleaning and disinfection schedule for the sterile area.
  • After completion of production, any material from the previous product should be removed from the sterile room to avoid cross contamination.
  • Cleaning and / or disposal of all support material should be done after each workday.
  • High standards of personal hygiene and cleanliness are essential for the personnel involved in the activity.
  • Gloves should be regularly disinfected during operations.
  • Masks and gloves should be changed at least every working session.
  • The hair and, where relevant, beard and moustache should be covered.
  • Protective clothing and appropriate shoes or overshoes should be worn.
  • Clothing used in clean areas should be laundered or cleaned in such a way that it does not gather additional particulate contaminants that can later be shed.
  • Grade A and B areas where activities are going on should be designed so that all operations can be observed from outside.
  • In clean areas all exposed surfaces should be smooth, impervious and unbroken to minimize the shedding or accumulation of particles or microorganisms.
  • After entering to the Changing room all personnel should confirm the correct fitting of garments with the help of mirror .
  • Consideration should be given to restricting unnecessary access to critical filling areas.

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