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  A. General Requirements

  Personnel Hygiene

  2.13 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.
2.16 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.

  B. Sterile Areas

  19. The clothing and its quality should be appropriate for the process and the grade of the working area. It should be worn in such a way as to protect the product from contamination. The description of clothing required for each grade is given below:

  Grade D: Hair and, where relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination coming from outside the clean area.
Grade C: Hair and where relevant beard and moustache should be covered. A single or two-piece trouser suit, gathered at the wrists and with high neck and appropriate shoes or overshoes should be worn. They should shed virtually no fibres or particulate matter.
Grade A/B: Headgear should totally enclose hair and, where relevant, beard and moustache; it should be tucked into the neck of the suit; a face mask should be worn to prevent the shedding of droplets. Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and retain particles shed by the body.

  20. Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. For every worker in a grade A/B area, clean sterile (sterilised or adequately sanitised) protective garments should be provided at each work session. Gloves should be regularly disinfected during operations. Masks and gloves should be changed at least for every working session.
21. Clean area clothing should be cleaned and handled in such a way that it does not gather additional contaminants which can later be shed. These operations should follow written procedures. Separate laundry facilities for such clothing are desirable. Inappropriate treatment of clothing will damage fibres and may increase the risk of shedding of particles.

  USFDA Requirements

  A. General Requirements

  Specified garments must be worn when entering and inside the clean area. These shall be stored in the anteroom and not worn in non-clean areas.

  B. Non-laminar Airflow Clean rooms and Work Stations

  1. Garments shall be pocket-less, lint-free coveralls, with snug fitting fasteners at the neck, wrist, and ankles.
2. Lint-free caps must be worn and must completely cover the hair and head except for the eyes, nose, mouth, and chin.
3. Shoes shall be cleaned and covered with a non-shedding boot-type cover or changed to approved clean room footwear. If special footwear is provided, it shall not be worn outside the clean room and dressing room.

  C. Laminar Airflow Clean Rooms and Work Stations

  1. Garments may vary with the operation being performed, but the minimum garment shall be a pocketless, lint-free smock which extends to at least 15 inches below the work surface. The collar and cuffs shall have fasteners.
2. 2. Head covering shall be worn, and shall completely cover the hair. If the operation requires the wearer to lean over the work, or move into the airstream between the filter bank and the work piece, the front, sides, and rear neck areas of the head shall also be covered.
3. Shoe covers are not necessary for vertical or horizontal laminar airflow facilities except when the work is being performed less than 24 inches from the floor.
4. A face mask may be needed if an operator has a cold, or if the nose and mouth must be brought very close to the work piece for work on miniature components or devices. Check with your supervisor for instructions.

  D. Clean Room Personnel Rules

  Personnel will be asked to cooperate in maintaining a low contaminant emission rate by observing the following rules.

  1. Bathe at night, instead of in the morning, to allow the build-up of normal body oils which reduces skin shedding. Also, use skin lotions.
2. Wear clean, unstarched, low-shedding garments.
3. Where appropriate, shave daily and be clean shaven or wear appropriate hair covering.
4. Avoid touching, rubbing, and scratching exposed areas of the body.
5. Exercise extra care to rid the hands of normal residue from home duties such as starching, baking, plastering, wallpapering, painting, concrete work, carpentering or other particulate generating activity.
6. Request duty outside the or away from the clean room area when you have a cold or other viral or bacterial infection.

  Schedule M Requirements

  1. This section covers garments required for use by personnel working only in aseptic areas. Outdoor clothing shall not be brought into the sterile areas.
2. The garments shall be made of non-shedding and tight weave material. Cotton garments shall not be used. The garments shall shed virtually no fibers or particulate matter.
3. The clothing and its quality shall be adapted to the process and the work place and worn in such a way is to protect the product from contamination. Garments shall be single piece with fastenings at cuffs neck and at legs to ensure close fit. Trouser legs shall be tucked inside the cover boots. Suitable design of garments shall either include a hood (head-cover) or a separate hood which can be tucked inside the over-all pockets, pleats arid belts shall be avoided in garments, Zips (if any) shall be of Plastic material. Garments with damaged zips shall not be used.
4. Only clean, sterilized arid protective garments shall be used in each work session where aseptic filtration and filling operations are undertaken and at each work shift for products intended to be sterilized, post filling. The mask and gloves shall be changed at every work session in both instances.
5. Gloves shall be made of latex or other suitable plastic materials and shall be powder-free. These shall be long enough to cover wrists completely and allow the over-all cuff to be tucked in.
6. The footwear shall be of suitable plastic or rubber material and shall be daily cleaned with a bactericide.
7. Safety goggles or numbered glasses with side extensions shall be used inside aseptic areas. These shall be sanitized by a suitable method. Garment changing procedure shall be documented and operations trained in this aspect. A full size mirror shall be provided in the final changes room for the operator to verify that he is appropriately attired in the garments. Periodic inspection of the garments shall be done by responsible staff.