Cross-contamination, Before taking steps regarding Prevention of Cross-Contamination during processing, this is very important to know basic about contamination and Cross-Contamination and what is the basic difference between contamination and Cross-Contamination.
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Mix Up, Contamination and Cross Contamination in Pharma industry
Cross-contamination
Cross-contamination can be defined as unintentional transfer of chemical contaminants (including allergens), microorganisms, or any other foreign substances from person, food, or object to another person, object or food product.
This problem is generally occurs at raw food to RTE[ready-to-eat] products, also occurs between allergen free and allegen products.
Cross-contamination products can cause severe food poisoning as harmful bacteria transfer from RTE products which doesn’t subject to any type processing or treatment on not taken any steps to eliminate harmful bacteria from those foods[RTE]. The best example of cross contamination is transfer of bacteria from raw food to cooked food.
Pharmaceutical products are the highest risk of Cross Contamination. Presence of small amount of antibiotics or trace amount of potent drugs cause severe damage to the patients. Carryover of one products residue to another products is consider the highest risk to the patient.
In the recent year, as per UK MHRA[United Kingdom Medicines & Healthcare Products Regulatory Agency], product contamination is the second to third cause to recall products from the market.
Understanding Cross-Contamination
There are several ways to where cross-contamination can occur:
- Equipment to food
- Food to food
- People to food
Equipment to Food
Contamination can be transfer from pantry equipment & utensils to food staff. This type of contamination can be transfer from improper cleaned equipment or utensils to food items and which is not properly sanitized before each use. Here is some example-
- Using of improper cleaned items such as utensils, slicers, knives, grinder, and juicer to prepare food.
- Using of cutting and chopping board and use the same knives to cut different food items, such as cutting raw beef and then prepare vegetable salad or RTE food items.
- Storing RTE [ready-to-eat] food items in an improperly sanitized container, which was previously used for raw food item such as raw beef.
Food to Food
Food can contaminate by bacteria from comes from other foods. This type of cross-contamination seriously dangerous when raw type foods contact with cooked/finished food/RTE Food. Here is some example for of food-to-food cross-contamination-
- Storing raw chicken in the upper shelf of the refrigerator but cooked chicken store lower shelf of the refrigerator where cooked chicken dripping from raw chicken.
- Raw meat placed on a on a grill touching another meat that is being cooked.
People to Food
Personnel can be great source of cross-contamination to food items for their inappropriate behavior or lack of training to do the task properly. Here is some points to notify the situation-
- Handling of food items just using after the toilet without properly personal clean up.
- Touching Raw Chicken and prepare vegetable salad without properly clean up between the tasks.
- Handling of apron with wipe hand and subsequently serve foods to individual.
- Using of towel to clean the kitchen and further use the towel after dry hand.
How to prevent cross-contamination
Production & Related Area
- All type of line clearance should be perform as per approved SOP and related checklist mentioned on BMR/BPR
- Avoid similar type of product clearance in same time in side-by-side line.
- All the system must be properly validated [Equipment/Machine/Facility/System/Process etc.]
- Before starting of any type of product processing, processing product, list of materials, printing materials, primary packaging materials must be contamination free.
- Check any type or related starting materials, product residues, products, documents, records, process flow and related documents of the previous products during starting of the new line.
- Closed system to be introduce for critical products, if possible close system to be introduce for all type of products handling.
- Campaign production may be the best procedure to achieve satisfactory contamination/cross-contamination free products by following appropriate validated cleaning procedure.
- During processing, products and direct products contacts part should not be handled with bare hand, use latex free gloves to handle the same with properly spray cleaned with IPA [70% IPA]
- During production/processing all type of maintenance work must be prohibited and production/processing to be stop during maintenance activities.
- If any area subject to maintenance activities, to restart of the operation, the area must be properly cleaned and maintenance clearance to be ensure from respective department.
- Packaging must be properly segregate from processing/filling area, a physical barrier must be introduce to prevent contamination and related operation must be controlled.
- Product subject to in process control in production area to be confirm that it should not provide the risk for the product and remaining IPC products must be discard and not to add the processed products.
- Production accessories/stationary/liquid item/ink of image printer/other solvent etc. must be kept in labelled container as per their content present in the defined container.
- Single line processing to be introduce, never start multiple line/product in the same line
- Solution container subject to filling should be properly cleaned before using for filling operation especially for aseptic products such as eye drops, which cannot be terminally sterilized due to container criteria [Plastic container].
- Try to reduce bioburden especially for injectable products and remove outer additional/unnecessary/additional wrapping during delivery at the point of use.
Clothing & Hygiene
- Appropriate clothing and gowning system to be ensure as per classified area.
- Clothing should be different for every shit/working hour/every time before entering the processing/filling area.
- Cleaning agents to be use in proper quantity and agents must be contamination free
- Clothing and its quality should be appropriate for the process and the grade of the working area.
- Daily environment monitoring by particle counter machine, air sampling, settle plate count to be carried out as when appropriate.
- During handling of hazardous material/container/liquid/gas, appropriate PPE[Personnel Protective Equipment] should be ensure.
- Footwear to be clean properly and each pair of clean shoe to be confirm before entering to the processing/filling area.
- Lint free non-shedding cloth to be ensure.
- Minimize the exposure of body surface as less as possible.
- Repeated wear of same gown in same days must be avoid in processing/filling area.
- Separate/dedicate PPE to be ensure for beta-lactam and non-beta lactam, other antibiotics, hormone, generic medicine, cytotoxic etc. products.
- Slippery sandal/shoe/loose shoe etc. to be avoid and appropriate shoe to be use such as lint free clothing shoe to be ensure especially in sterile processing/filling area.
- Wash the cloth each time before entry of the process room.
- Washing system to be separate as per designated area.
Utilities and Service
- Appropriate water to be use in pharmaceutical preparations for its targeted use.
- Any type of failure regarding water quality test must be notify and action to be taken and production must stop.
- Chemical and microbial limits and requirements must be made.
- Validation of the water system to be ensure before using water in pharmaceutical preparations especially First and Second phase must be validate and third phase must be ongoing and report should be made.
- Water quality must be check before its use.
Steam Quality
- PQ[Performance qualification] of steam to be ensure.
- Pure steam and industrial steam to be use as when and where appropriate.
- Steam must be additive free.
- Steam must be contamination free and microbial quality must be passed.
Compressed air/Transportation/Cleaning and related activities
- Air quality to be ensure by passing through appropriate filter.
- Any sign of spillage/broken/contamination during transport, full quantity must me discard.
- All type of processed or partially processed, in-process materials, raw materials, partially packed, finished packed should be properly labelled with Product Name, Batch no., Quantity, Packed by, Packing date, Manufacturing date, Expiry date etc.
- Cleaning solvent/materials use for cleaning, lubrication, pest control should not direct contact to the product and suitable grade of cleaning agent to be ensure.
- During production, high degree of cleaning and sanitation to be ensure before entering into the processing/production area.
- Measures must be taken to prevent cross-contamination and its effectiveness to be ensure.
- Processing/manufacturing area for hormones, penicillin, cephalosporin, generic products, vaccine, antibiotics must be dedicate/segregate to prevent cross-contamination.
- Transport of Beta lactam and non-Beta lactam antibiotics should not be perform in disclose condition, container must be tightly bind with the appropriate material/stripe. Finished product may be transport with tight pack condition simultaneously.
- To be clean/clean label should be properly attached on any containers subject to use or unused with product/material name/batch no.