There are several ways to prevent cross contamination during production and below are some ways to do so. Before starting, line clearance should be performed as per the SOP of the company. Do a checklist and record. Check to see if any starting materials are missing, previous record documents, product residues and product itself. Practice a closed system when handling the materials.
Different Types Of Contamination, Causes And Prevention For Pharmaceutical Industry
The presence of unwanted materials such as dust and particles during the manufacturing and transportation time is called contamination. The term contaminants includes any unwanted matter that is found in the product. These contaminants affect the quality of the product or the process.
The most common types of contaminant include:
- Physical contamination. Examples: fiber material, particles, chips from your pill press tooling.
- Chemical contamination. Examples: vapor, gasses, moisture, molecules.
- Biological contamination. Examples: fungus, bacteria, virus.
Cross contamination is possible when the unwanted matter is introduced or brought from one process to the next during manufacturing.
A leak in the holding containment would contaminate the product inside it; this would be an example of physical contamination.
For chemical contamination, an example would be when the product is stored in a container that previously held another product, but was not properly cleaned. The remaining product’s chemical composition may add impurities to the new product, causing it to become contaminated.
For biological contamination, bacteria may thrive if the container is not properly cleaned and dried. The contaminated container will then affect the product and microbes may thus be introduced to the batch.
Causes of Biological Contamination:
- Unhygienic and unsanitary practice
- Improper work attire
- Use of contaminated materials and equipment
- Open wounds or lesions in operators
- Operators suffering from infectious disease
Prevention of Contamination:
- Determine the cause of the contamination
- Anticipate the effect
- Prevent any ingress and egress
- Minimize the effects and quarantine the area
- Control the remaining contamination
Process of Elimination:
- Eliminate the source material
- To remove the contaminant carrier:
- Reduce human involvement
- Regulate the use of the equipment
- Regulate the use of air
- Regulate the use of water
- To reduce human carrier risk:
- Ensure that proper attire is worn when coming and going from the production area
- To reduce water as carrier:
- As water is the number one source for cross contamination, it is important to reduce and prevent water contamination
- Water borne contaminants: particulates (such as minerals) and pathogens (e. coli, salmonella, etc..
- Use of preventive measure such as filtration devices, distillation or reverse osmosis, UV treatments
- To reduce air as carrier:
- Control air flow through AHUs
- Use of air locks
- Installation of HEPA filters
- Ultra-Low Particulate Air
Tips to Prevent Contamination
- Test one material at a time to prevent cross contamination
- Take a sample in a room that has a suitable air control system to prevent contamination through airflow
- Use proper tools designed for the product
- Ensure proper cleaning of equipment to prevent any biological contamination
- Regularly check if the cleaning process is effective
- Regularly check equipment for wear and tear to prevent any compromise to its integrity
- Properly design airflow system to prevent airflow contamination
- Dispensing stations should have proper dust extraction system
- Do not return used samples to their original containers
- Regularly monitor water to check for presence of microbial system
- Avoid charging two materials at a time
- Avoid unloading different materials for different batches
- Line clearance must be observed during product changeover
- Total impurity must not exceed 0.5% and single individual impurity not more than 0.1%
We at LFA Tablet Presses don’t only sell pill presses. We also support our customers in setting up their business. Contamination can be a really big problem in the food, pharmaceutical and chemical industries. If you need help with reducing contamination please do get in contact with us.
A Mix–Up may be defined as:
- An unplanned combination of various compounds.
- A mistake brought about wrongly identifying one material for another.
A mix-up can be caused by bad judgement or lack of attention to detail, i.e., human error. It can also occur though poor communication between personnel.