Cleanroom behavior & personal hygiene

Cleanroom behavior & personal hygiene

1.0      PURPOSE:

To describe the procedure for personal hygiene & behavioral approach during clean room operation.

2.0.     SCOPE :                                  

This SOP will be applicable for behavioral approach & personal hygiene for all the Staff, operators & workers of clean area of SVP section


3.1        References

3.1.1     Schedule M & cGMP guidelines

3.1.2     WHO-TRS 961 guidelines

3.2        Attachments:

3.2.1     N/A


4.1       Operator:

4.1.1    To follow all the instructions described here in.

4.2        Production  Person/Designee:

4.2.1    To verify that employees are trained before performing or operation any task relevant to this SOP.

4.2.2    To Maintained the record.

4.3        Production Head:

4.3.1    To ensure the compliance of SOP.

4.4        Quality Assurance Persons:

4.4.1    To verify that all the instructions are followed properly as per the given SOP.

4.4.2   To ensure implementation of the SOP.


  1. Production
  2.  II.   Quality Assurance.


6.1       Definition

Clean Area :Clean area is the area in which defined environmental control of particulate  & microbial contamination, constructed & used in such a way to reduce the introduction, generation & retentions of contaminants within the area.    

6.2      Abbreviations

SOP  : Standard Operating Procedure

QA   : Quality Assurance

PROD. : Production

C.C. No.  : Change Control Number

SS   : Stainless Steel.

IPA  : Iso Propyl Alcohol

LAF  : Laminar Air Flow


7.1 Personal hygiene:

7.1.1 Personnel should have a good level of personal hygiene as problems of dandruff, dry skin and hair fall & dirty nails can cause contamination.

7.1.2 Cosmetics, rings, watches, mobile, eating, gum chewing and jewelry are not allowed into the clean room.

7.1.3 Smokers must ensure that they have not smoked minimum two hours before entering the clean room.

7.1.4 Personnel with skin conditions, respiratory conditions and allergic conditions like sneezing, itching, scratching, running nose, fever & wounded shall not be suitable for  work inside the clean room, should be assigned a job outside the clean room area.

7.1.5 All personal items such as keys, watches & rings should be stored in the personal locker in main change room.

7.1.6 Cosmetics should not be worn in the clean rooms. This includes: lipstick, eye shadow, eyebrow pencil, eye liner, false eye lashes, fingernail polish, hair spray, or the heavy use of aerosols, after shaves and perfumes.

7.1.7 Authorized person to be enter in clean area should be properly clean and shaved.

7.1.8 He should be trained with gowning practice.

7.1.9 During entry in the clean room hand should be properly sanitize with approved hand sanitizer.

7.1.10 Training of hand disinfection & proper rubbing should be given to each employ working inside clean room.

Prohibited items inside the clean room:

 Nothing shall be allowed inside the clean room which is not required for production.

  • Food, drink and chewing gum.
  • Cans or bottles.
  • Radio, Cell phones, Personnel Laptop, Camera & Pages etc.
  • Newspapers, magazines and books.
  • Pencils and erasers.
  • Wallet, purses and similar items.
  • Personal handkerchief.

Behavior & discipline inside the clean room:

  • Silly behavior shall not be allowed.
  • Personnel should not lean over the product in such a way that particles or fibers fall from the personnel over the product.
  • Personnel shall not support the materials against their body.
  • Personnel shall not talk while working over a product.
  • In case the personnel cough or sneeze, ensure that the head is turned away from the product. Also replace the mask with a fresh one.
  • Care should be taken to ensure that the mask is worn correctly over the nose and not below the nose.
  • Do not touch the work surface, disinfect the gloved hands frequently.
  • Noses should not be blown inside the clean room.
  • Clean room person should give continuous training to remind them they must not touch any critical equipment, product with naked hand.

Entry and exit to clean room:

  • Doors should not be closed or opened quickly.
  • When passing through the doors in an airlock, personnel should ensure that the first door is closed before going through the next one.
  • Only the essential and trained personnel should be allowed into the clean room.
  • The personnel in the clean room should be knowledgeable regarding the various aspects of contamination control.
  • Only approved lint free garment should be worn in clean room & during gowning be careful it should not touch on the floor.
  • Wear the hand Gloves and ensure that it is properly tuck over the cuff.
  • Gloved hand should not be allowed to touch any item or surface that has not been thoroughly cleaned.
  • Gloved hand should be disinfected frequently with disinfectant solution, after any maintenance work replace the gloves with new one and sanitize with 70% IPA solution.
  • Only approved gloves (powder-free) should be used in clean room.
  • Ensure that clean room gown is properly worn.
  • Solvent contact with the bare skin should be avoided. they can remove skin oils and increase skin flaking.
  • No tool should be allowed to keep on the surface of a bench or table.
  • Always walk normally and slow motion in clean room, Fast motions such as running,walking fast or horseplay should not be encouraged due to generation of more particles.
  • Sitting or leaning on equipment or work surfaces is not allowed.
  • Writing on equipment or garments is prohibited.
  • Removal of items from beneath the clean room garments is restricted.
  • Don’t wear the clean room garment outside the clean room.
  • Don’t wear torn or soiled garments.
  • Never work alone, a buddy is required in the clean room at any time.
  • Hands shaking is strictly prohibited.
  • In case of evacuation alarm, follow the safety rules.
  • Only trained staffs are allowed to operate the machines/to do the clean room activity.

Handling of materials(mold/maintenance parts/machine parts):

  • The movement of materials inside and the outside of the clean room should be minimized.
  • Before transfer the material(mold, maintenance parts/machine parts etc.) in the clean area first clean the same with lint free cloth.
  • Then wipe out the same thoroughly with 70% v/v IPA solution & allowed to dry the traces of IPA.
  • Properly verify that there should be no visible particle on the material to be transfer.
  • Then wrap the poly film on the material(mold, maintenance parts/machine parts etc.) and again clean the material with film with 70 % v/v IPA solution in Air lock Ist.
  • During transfer of material(mold, maintenance parts/machine parts etc.) again clean with IPA 70% v/v in the Air lock III & transfer in the clean area.

7.6  Maintenance and Service personnel:

7.6.1      Maintenance and service operators shall enter the clean room only with permission of section head & will follow proper entry/exit procedure.

7.7         Special attention: 

7.7.1      Visitors  shall be allowed in only under the control of trained production person.

7.7.2      Unwanted movement of the person in and around the sterile area is strictly prohibited.

7.7.3      Photograph shall not be taken unless permitted by Plant Manager.


Version No. 00 Effective date

Detail of revision :New SOP


About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also


VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of …