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.
Contaminants Caused By Humans And Methods Of Control
Contamination is a major problem with sterile manufacturing, and also one of the most important to control. Cleanrooms are required that are kept free from contaminants at all times, but are difficult areas to maintain. The cleanroom can also be a major source of contamination if not kept clean and sterile are all times. The biggest source of contamination however is humans who work with the products.
Airborne disease from people can easily contaminate both the cleanroom, equipment and products being made. In addition, during processes such as milling, sifting and compression, the materials can easily be contaminated with both visible and non-visible particles such as dust or powders.
Controlling contaminants is an important part of the manufacturing process; however, there are simple methods that can be followed to reduce the risk, which mostly include making employees aware of possible routes of contamination and how to avoid them. Common sources of contamination from humans include hair and fingerprints. Even one’s breath can contain bacteria and saliva that could contaminate a sterile environment.
A training program is a good way by which all employees and staff working around sterile environments can be made aware of the importance of preventing contamination. Below are some key topics that can be discussed with employees:
- Personal items such as jewellry, phones, keys and cigarettes should not be allowed in working areas
- Food and drink is not allowed at any time in working areas, including chewing gum and smoking
- Hair caps should be mandatory
- Avoiding excessive body contact where possible, including hand shaking
- Pens and paper should be approved and not excessively removed from the working area
- All doors should be closed properly
- Lint free cloth should be used where possible
- Line clearance must always be observed before starting manufacture
- Pressure differentials and temperature should be checked and maintained
- Airflow pattern and velocity should be checked regularly
In order to protect employees and ensure the risk of contamination is limited as much as possible, human activities must be restricted to ensure all working areas are maintained in a sterile environment where needed and free from contaminants at all times.