ASEPTIC TECHNIQUES/BEHAVIOUR

ASEPTIC TECHNIQUES/BEHAVIOUR

 

A clean room is a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary. ”

The basic function of a clean room is to protect the drug product/substance from contamination. Air born contamination from outside air is an ordinary problem associated with clean rooms.

The biggest source of contamination in the clean room is personnel. Clean rooms should maintain with minimum number of the personnel. Adherence to basic aseptic technique is a continues requirement for operators in an aseptic processing operation.

ASEPTIC TECHNIQUES

1.	Contact Sterile Materials only with sterile instruments: Sterile instruments (e.g: forceps) are should always be used in the handling of sterilized materials. These instruments should be replaced as necessary throughout the operation.   After initial gowning, sterile gloves should be regularly sanitized to minimize the risk of contamination. Personnel should not directly contact sterile products, containers, closures or critical surfaces.
2.	Moving slowly and deliberately: Rapid movements can create unacceptable turbulence in the critical zone. Such movements disrupt the sterile field, presenting a challenge beyond intended clean room design and control parameters. The principle of slow, careful movement should be followed throughout the clean room.
3.	Keeping the entire body out of the path of laminar air: Laminar air flow design is used to protect sterile equipment surfaces, container closures and the product. Personnel should not disrupt the path of laminar flow air in the aseptic processing zone.
4.	Approaching a necessary manipulation in a manner that does not compromise sterility of the product : In order to maintain sterility of nearby sterile materials, a proper aseptic manipulation should be approached from the side and not above the product (in vertical laminar flow operations) Also speaking  when in direct proximity to an aseptic processing line is not an acceptable practice.

 

ASEPTIC BEHAVIOUR

1.	Only qualified persons are allowed to enter the clean room.
2.	The personnel who entering in the aseptic processing area should be gowned properly. An aseptic processing area gown should provide a barrier between the body and exposed sterile materials and prevent contamination from particles generated by and microorganisms shed from, the body. Gowns needs to be sterile and non shedding, and should cover the skin and hair. If an element of gown found to be torn or defective, it should be changed immediately.
3.	Gloves should be applied in such a way to prevent contamination of the glove surface. The most widely recommended method is to grip the gloves at the wrist and slide the gloves onto the hand, without touching the surfaces of the glove that will later come in contact with items in the clean room. Gloves should be applied last, immediately before entering the clean room.
4.	It is recommended that personnel entering the clean room do not open the door with their gloves to prevent particles from the door from contaminating them.
5.	Only clean room compatible materials are allowed in clean rooms.
6.	Personnel should attempt to avoid coughing or sneezing as much as possible, but if it cannot be avoided, you should turn your head and try to direct it away from the item you are working with as much as possible. Because the face mask is an imperfect seal, particles can easily get around the mask when you cough or sneeze. Masks are often replaced after sneezing or coughing.
7.	The primary source of particulate contamination in the clean room is users and the rates at which users shed particles correlate to the level of physical activity or motion by the individual. Keep movements to a minimum and avoid activities like pacing, extraneous walking, or horseplay.
8.	The number of personnel working in the clean room to be minimized  at any given time.
9.	Person should always be correctly positioned in relation to the production process. For instance it is bad practice to lean over the product because this would allow the particles from clean room garments to fall on to and around the product.
10.	Speaking should be avoided when working close proximity to a product.
11.	Avoid touching surfaces within the clean room
12.	Hands should be held away from the clean room garment to reduce the risk of contaminating the gloves.
13.	Clean room gloves should be cleaned on regular basis to reduce the risk of transferring contaminants by touch.
14.	Cloths used in clean rooms should be used only once or a predetermined number of times. After use a clean room cloth should be discarded.