Most common types of pharmaceutical contamination
Contamination can lead to objectionable results in the Pharma industry. It can conciliate the safety of patients, staff, and the environment – as well as affect the market.
High standards of hygiene are important to maintain, only preventing the bio-burden levels by means of effective cleaning is not sufficient: it’s equally important to identify and prevent possible contaminants.
In this article, we talk about the types and the most common sources of pharmaceutical contamination and list the most effective control point that you can apply to prevent contamination throughout the whole activity.
Common types of pharmaceutical contamination
The most common contaminants found in pharmaceutical products are:
- Physical Contaminants: These include chips, particles, and fiber materials that can enter the manufacturing or packaging process and contaminate the entire batch.
- Pyrogenic Substances: Micro-organisms that can cause fever.
- Chemical Contaminants: Moisture, gases, vapor or molecules may also contaminate sterile pharmaceutical products.
- Biological Components: Like viruses, bacteria, or fungi that can cause diseases and should not be found in pharmaceutical products.
Potential sources of contamination in pharmaceutical products
To effectively prevent contamination and ensure high levels of safety in pharmaceutical manufacturing, it is crucial to identify the sources of contaminants.
- Personnel: People who are involve working or supervising pharmaceutical manufacturing and packaging processes can be a significant source of contamination. Generally This happens due to:
- Lack of training
- Inadequate cleanliness and hygiene standards
- Direct contact with the materials & products
- Lack of personnel protective equipment and appropriate clothing
- Malpractices like eating or drinking in the manufacturing or storage areas
- Entry or use of key manufacturing units by unauthorized personnel
- Manufacturing facility: The facility or the building may be another primary source of contamination because of:
- Poor design and inadequate space that can lead to cross-contamination and mix-ups
- Lack of adequate pest control and waste management measures
- Improper ventilation, lighting, and air filtration system
- Inadequate cleanliness and sanitization practices
- Materials: The quality, handling, and control of raw materials can also cause pharmaceutical contamination by:
- Improper handling and storage
- Poor labeling, sampling, and testing of raw materials
- Degradation of materials due to environmental conditions
- Using materials that do not meet acceptance guidelines
- Manufacturing process: There is a high chance of contamination throughout the manufacturing process because of:
- Lack of dedicated production facility for each product
- Absence of statutory-compliant hygiene and cleanliness standards
- Lack of proper zoning, resulting in mix-up or cross-contamination
- No or insufficient cleaning and maintenance status labeling on materials and equipment used in the manufacturing process
- These are some potential causes of contamination in the pharmaceutical industry which must be efficiently addressed to manufacture high-quality and safe products for all.
The chances or sources for contamination in the pharmaceutical industry always exist. Taking effective adequate preventative measures and effective training can help to maintain high standards for quality and comply with regulatory authorities.
Once you identify the sources that may be potentially contaminated pharmaceutical processes and products, it is crucial to have definitive preventive measures in place. We can eliminate /minimized pharmaceutical contamination following the below-mentioned procedure:
- Manage Personnel Contamination: Ensure the personnel involved in the production and handling process is highly qualified and have professional training in hygiene and cleanliness. Make sure there is always hygienic clothing available and stress that protective gowning must be worn at all times
- Disinfect: Regular cleaning and sanitization is the core of preventing pharmaceutical contamination. In addition to thoroughly cleaning and disinfecting the facility, cleanliness, and hygiene of gowning is also important.
- Improve Facility Design: The facility design should comply with regulatory standards, ensuring that humidity, temperature, room pressure and air filtration is properly maintained. Using UV airlocks, restricted access barrier systems, or laminar flow in manufacturing or packing areas will help eliminate particles and other contaminants.
- Regulate Water Use: To prevent water-borne contamination, make sure that only distilled water is used in manufacturing pharmaceutical products.