1.0 Introduction:
1.1 Cross contamination:
- Contamination of a starting material or intermediates or finished products by another material or product during the production is called cross contamination.
1.1.1 Sources:
- The main sources of cross contamination are human beings, equipment, air, raw materials and water.
- Human beings serve as carriers for microbial contamination like staphylococcus species during manufacturing process. This may also serve for introducing microbial species into medicines which may be life threatening and may cause allergic reactions. Sometimes the microbes may be resistant to antimicrobials.
- Use of such cross contaminated drugs may cause sepsis in the patients taking them
- Handling of Penicillin products need special caution as some personnel may be sensitive to them. These may also be cross contaminated during campaign process and may cause severe anaphylactic reactions
- In cases where in same production line more than one drug is manufactured which causes cross contamination
- Air carries many organic & inorganic particles which may contaminate the product and degrades its quality
- Water may also contamination when the pipe that carries water is not sanitized
1.1.2 Preventive measures:
- To prevent cross contamination the personnel should be taught of gowning practices and maintaining of personal hygiene.
- The personnel should wash their hands regularly.
- Penicillin like sensitive products should be handled carefully as they may cross contaminate and cause fatal effects. Hence there production should be carried in dedicated facilities
- Separation in time along suitable cleaning procedures ensures that cross contamination doesn’t occur when more than one product is produced in same line of production
- Proper air filtration systems should be installed to prevent contamination by air with aptly designed air supply extraction system. Filters should be cleaned regularly
- Pipes should be sanitized as per the written procedures
1.2 Mix Up
- Mix up is the contamination of one product with another product by human errors or inadequate process or plant design.
1.2.1 Sources
- Mix ups occur during labelling, packing, line clearance problems or receipting
1.2.2 Preventive measures
- Physical segregation of the products with proper labelling and identification details
- Proper design for the flow of materials
- Packing should be done in compliance with the written procedures
1.3 Good manufacturing practices to avoid Contamination & Mix up:
- Procedures should be clear and should be followed to achieve the objective of quality for the product.
- All the procedures regarding materials and products regarding their receipts, sampling, storage, cleaning, labelling, quarantine and dispensing should be in accordance with written procedures
- Precautions should be taken so no deviations from procedures and instructions occur and if deviations occur then they should be treated as said in procedures
- To avoid discrepancies from acceptable limits yields and quantities should be checked
- Operations on different products should not be conducted in the same premises to prevent cross contamination or mix up
- At each step in processing every material and equipment should be labelled with their indication, batch number and strength. If applicable then the stage of production should also be mentioned and few cases also mandate the name of the previous product that is processed.
- The production premises should be accessed by only personalized personnel
- Non medicinal products should not be produced in places where the equipment and pharmaceutical products are produced.
- Care should be taken so that the in process controls don’t impact the product quality or any other product as in case of mix up or cross contamination
1.4 Related documents
http://ihi.eprints.org/3131/1/MATHIAS_Eulambius.pdf
