Contaminants can enter the manufacturing process from various sources, including personnel, poorly designed utility systems, HVAC systems, production machinery and equipment, raw materials, intermediates, packaging materials, and general facilities. The primary sources of contamination are listed below.
Employees
Employees who perform work or supervise production are potential sources of microbial and other contamination. The main reasons for contamination through employees are as follows:
1- Lack of training
2- Direct contact of operators’ hands with raw materials, primary packaging materials or intermediate materials and bulk products
3- Inadequately trained personnel
4- Access of unauthorized persons to warehouses and controlled areas
5- Inadequate coverage of personnel and equipment
6- Improper behavior such as eating, drinking, using tobacco in warehouses and production operational areas
Buildings, facilities and equipment
Buildings, equipment and production facilities may contribute to contamination. The main reasons for contamination related to facilities and equipment are as follows:
1- Inadequate size and improper structure of production spaces that cause errors and mistakes in work such as mix-ups or cross-contamination between raw materials, materials in production and finished products
2- Inadequate pollution and pest (insect) controls
3- Rough ceilings, floors and walls
4- Poor and incomplete air filtration system
5- Inappropriate location of roads Water
6- Inadequate lighting and ventilation
7- Inadequate and improper washing and cleaning of toilets and improper building design that does not allow effective cleaning and disinfection of equipment and devices and the building.
Equipment
Equipment and devices in the transfer of materials and packaging of materials are common and common sources of contamination. The main reasons for the transfer of contamination by devices include:
1- Improper design, size, rust and corrosion, accumulation of static materials and fraud in the mode of disinfection, cooling and lubricants
2- Improper cleaning and disinfection
3- Improper calibration and irregular and irregular services
4- The use of defective devices Materials and raw materials used in the production process can be potential sources of contamination.
The main reasons for the transfer of contamination from potentially contaminated materials are:
1- Improper storage and handling can cause mix-ups.
2- Contamination with microorganisms or other chemicals
3- Decomposition of materials by environmental factors and conditions such as heat, cold, light and humidity
4- Improper labeling
5- Use of materials that are not within acceptable conditions and limits.
Production process
There are various ways for contamination of raw materials, intermediates or packaging materials in the production process. The main reasons for contamination during the production process are:
1- Lack of independent facilities for the production of a product
2- Improper cleaning between production batches to minimize
3- Change and impact on the product
4- Use of a remanufacturing system and exposure of the product to environmental conditions
5- Improper zoning and classification
6- Appropriate labeling system for cleaning devices and equipment and materials to minimize the risk of production contamination
Production of products in a process with appropriate cleaning and checking the production process between different batches to prevent product changes. Use of a closed system for production, in this case the product is not exposed to environmental conditions.
Classification
Use of cleanliness status labels for equipment and materials used in the manufacturing process
Hvac System
A poorly maintained HVAC system can allow the transfer of microorganisms and other particles. The main causes of contamination by HVAC are:
1- Accumulation of marine organic matter near the HVAC inlet
2- Inefficient filtration of the supply air
3- Improper pressure differentials that cause air flow to reverse.
4- Lack of access to the ventilation system, filters and vents from outside the production
5- Non-directional airflow in the production and regular handling of raw materials and packaging
