sop for prevention of cross contamination

1.0 OBJECTIVE 
1.1 The objective of this SOP is to define the procedure for checks follows for prevention of cross contamination.
2.0 SCOPE
2.1 This SOP is applicable for various system controls to prevent cross contamination in manufacturing and packing area in factory premises
3.0 RESPONSIBILITY
3.1 Asst. Officer or above -Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager-Quality Assurance -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance Department

5.0 ENVIRONMENT, HEALTH AND SAFETY
5.1 According to below mention procedure
6.0 PROCEDURE
General points mentioned should be adhering to avoid cross contamination.
6.1 PREMISES AND PERSONNEL
6.1.1 Premises should be situated in an environment which considered together with measures to protect manufacture present minimum risk of causing cross contamination of material or products.
6.1.2 Premises should be carefully maintained ensuring that repair and maintenance operation do not affect any hazards to the quality of products. The premises should be cleaned and where applicable disinfected as per standard procedure. Routine Sanitization of premises should be done as per SOP. Departmental procedure should be followed.
6.1.3 The building should be designed and equipped with maximum protection against entry of insects or other animals.
6.1.4 Storage space should permit the orderly and logical positioning of equipment and material wherever applicable storage area should have adequate area to minimize risk of confusion between different products or other components.
6.1.5 Manufacturing of product should be carried out in clean area entry should be through air locks for personnel and equipment.
6.1.6 Interior surface walls floors and ceiling should be smooth free from cracks and open joints and should not shed particulate matter and should permit effective cleaning and disinfecting.
6.1.7 Pipe work light fitting ventilation points and other services should be designed and sited to avoid the creation of reaches which are difficult to clean.
6.1.8 Weighing of starting material should be carried out in separate cubicles / areas under reverse laminar air flow units.
6.1.9 A separate sampling area and dispensing area should be available for starting materials.
6.1.10 During manufacturing closed system should be adopted where possible.
6.1.11 Packing area should be designed and laid out to avoid mix-ups and cross contamination.
6.1.12 Appropriately design airlocks processor differential air supply and extraction system should be preceded.
6.1.13 Entry of unauthorized people should be prohibited in areas of production, quality control and stores.
6.2 EQUIPMENT’S AND TOOLS:
6.2.1 Equipment should be installed inset away so as to prevent any risk of error or contamination.
6.2.2 Production equipment that come in contacts with product must not be reactive additive or absorptive to such as it will affect the quality of the products.
6.2.3 Dedicated equipment should be used for products.
6.2.4 Water distribution pipeline should have coupling and sloped for drainage.
6.2.5 Equipment should be kept in clean and maintained condition and records of maintenance must be kept.
6.2.6 Cleaning equipment or material that shed particles raises dust. Or otherwise generate contamination should not be used (use of bristle brushes, fiber- shedding cloths should be avoided).
6.2.7 Vacuum cleaner should be fitted with appropriate dust retaining filters.
6.2.8 When ever two or more similar machine are available in the area for same purpose then only same product shall be run at a time.
6.2.9 Separate usage log should be maintained.
6.2.10 At a time same product shall be handled on different equipment in the area.
6.2.11 Equipment should be installed Separate usage log should be maintained in such away to minimize any risk or error of contamination.
6.2.12 Fixed pipe system should be clearly labeled to indicate the correct direction of flow.
6.2.13 Production equipment should be thoroughly cleaned in schedule basis.
6.2.14 Washing cleaning and drying equipment should be chose and used so that cross contamination is prevented.
6.2.15 Defective equipment should be removed from production and all areas or it should be clearly labeled as defective equipment not to be used.
6.2.16 Common equipment should be cleaned according to validated cleaning procedure the production of different product to prevent cross contamination.
6.2.17 Current draining of critical equipment and support system should be maintained.
6.3 HVAC SYSTEM:
6.3.1 Air intakes not to be situated nearly wet drain air exhaust or source of dust.
6.3.2 Dedicated HVAC system with appropriate filter should be installed in all process area. Suitable air lock with pressure differential should be installed.
6.3.3 Separate area should be provided for cleaning of filter away from the AHU.
6.3.4 The risk of contamination caused by recalculation or re-entry of untreated or insufficiently treated air should be minimized.
6.3.5 In all room, air supply and exaction point should as to restrict the supply of clean air to work sites and/ or the sweep of dust or contaminates away from work site.
6.3.6 The air flow pattern and recirculated air should be designed to afford adequate protection to the product as well as operator safety.
6.3.7 Appropriate dust extraction system should be provided where applicable.
6.3.8 Care should be taken before of any operation in the processing area in the absence of any starting material product, products residues and document of previous product, line clearance should be adhere as per SOP.
6.3.9 Where handling of material use of closed system should be done where possible.
6.3.10 Ensure that only one product is handled at a time in the processing area with in the cubicle. Packing operation in the packing
6.4 PROCESSING OPERATION:
6.4.1 Packing hall should be carried out with physical segregation between packing lines.
6.4.2 At every stage of processing product of material particularly primary packing material should be protected from microbial & other contamination.
6.4.3 Clean common container & bin used in multi product facility thoroughly before every use to avoid cross contamination of products ensure that cleaning procedure is validated.
6.4.4 Outer wrapping of packing material in which they are delivered should be removed before being issued on the shop floor.
6.4.5 Equipment for filling operation should be cleaned before use. Attention should be give to avoid and remove the contaminants.
6.4.6 In process control may be carried out within the production area provided they do not carry any risk for production.
6.4.7 Product and product contact part of equipment should not be directly handled with bare hands, Double gloves should be used.
6.4.8 Conducting comparing production followed by appropriate cleaning in accordance with a validated cleaning procedure.
6.4.9 Essential material such as active material, ink, cleaning fluid should be kept in container that lock completely different from the container which are used in production and should be labeled to their content.
6.5 CLOTHING:
6.5.1 Clothing and its quality should be appropriate process and the grade of working area. It should be worn in such a way so as to protect the product from contamination. Ensure that clothing / linen is not of shedding type.
6.5.2 Clothing should be washed routinely at appropriate laundry facilities.
6.5.3 Separate washing facilities should be available for sensitive product.
6.5.4 During washing of linen / clothing ensure that they are not contaminated by cleaning agent.
6.5.5 Appropriate personnel protective equipment should be used where applicable when products with special risk are considered.
6.5.6 Linen/ clothing should be changed after every product change over.
6.5.7 Procedure for cleaning of foot wears.
6.5.8 Routine environment monitoring by particle count and plate exposure should be done.
6.6 UTILITY AND SERVICE:
6.6.1 Water system: – chemical and microbial limits should be appropriate to it intended use.
6.6.2 Steam: – Steam used should be free from additive cleaning; steam generator may be used where appropriate.
6.6.3 Compressed air:-compressed air should be pass through appropriate filter.
6.6.4 General:- material which are used for operation such as cleaning, lubrication of equipment and pest control should not come in the direct contact with product whenever possible such material should be suitable grade (food grade) to minimize the health risk.
6.6.5 Measure to prevent cross contamination and their effectiveness should be checked periodically according to set procedure.
6.7 CLEANING & SANITIZATION:
6.7.1 All equipment and tools shall be cleaned and sanitized as per approved standard procedure.
6.7.2 Floors & walls shall be cleaned by using disinfectant as per standard procedure.
6.8 HOUSE KEEPING
6.8.1 All the housekeeping tools like plastic broom, Wiper, Mop, plastic bucket shall be separated for sterile area.

7.0 ABBREVIATIONS

SOP : Standard Operating Procedure
CB : Cephalosporin Block
ID : Identification Number
QA : Quality Assurance
HVAC : Heating, Ventilation, Air Conditioning
AHU : Air Handling Unit