Contamination is one of the biggest problems in pharmaceutical industry, especially in sterile pharmaceutical manufacturing. It is very important to identify the source of contamination to manufacture safe pharmaceutical products.
Contamination in pharmaceutical products may cause problem in patient safety or regulatory penalty and product bans. Recently many pharmaceutical companies have been banned by United States Food and Drug Administration (FDA). This cause effect on their business as well as the company's reputation. By taking proper safety measures companies can protect products from contamination.
When external particles are present in the pharmaceutical product like fibers, any metal parts, any dust particle or any other particle from machine is considered a physical contamination. It any occur from packing process or during manufacturer process.
We can investigate the source of contamination by conducting visual inspection, looking for physical signs of source of contamination or any equipment malfunction. We can also talk to operators and manufacturing staff asking them questions those can help to identify the source. The determination of source of contamination will help us to prevent the reoccurrence of this issue again. Following are the different ways to prevent contamination in pharmaceutical products.
Contamination is a universal risk in pharmaceutical manufacturing industry. By taking adequate measures, you can minimize the risk of contamination. GMP regulations and written standard operating procedures (SOPs) can also minimize the contamination risk.
Contamination in pharmaceutical products may cause problem in patient safety or regulatory penalty and product bans. Recently many pharmaceutical companies have been banned by United States Food and Drug Administration (FDA). This cause effect on their business as well as the company's reputation. By taking proper safety measures companies can protect products from contamination.
Different Types of Pharmaceutical Contamination
The most common types of pharmaceutical contaminations are:
1. Physical Contamination
When external particles are present in the pharmaceutical product like fibers, any metal parts, any dust particle or any other particle from machine is considered a physical contamination. It any occur from packing process or during manufacturer process. 
2. Chemical Contamination
Addition of any chemical like cleaning agent or any other product materials into the product is considered a chemical contamination. Chemical contamination can occur in oral dosage forms as well as injectable products. These are difficult to identify visually and found during chemical analysis of product.3. Microbial Contamination
If product is exposed to environment for a longer period, some bacteria, viruses or fungus may enter into it, this type of contamination is called microbial contamination because it is caused by microorganisms. Sometimes it may be caused by human handling the products. None pathogenic microbes are also considered as contamination.4. Mix-ups or Cross Contamination
When two or more products are mixed without any intention during manufacturing it is called Cross Continuation. Cross contamination may cause unknowingly when residues of previous products are there in any manufacturing equipment. Most of the time it is cold due to improper cleaning of manufacturing equipment.Common Sources of Contamination
Contamination in pharmaceutical products may occur due to different reasons some of those are discussed here.1. Personnel Hygiene
People who are working in manufacturing area can be the major source of contamination. It happens due to improper training, inadequate cleanliness and hygiene, direct contact with material and products, lack of using PPEs and eating or drinking in manufacturing area.2. Manufacturing Facility and Equipment
Manufacturing facility and equipment may other primary cause of contamination in pharmaceutical products. Improper design or inadequate space in manufacturing area can lead to mix up and cross contamination in different pharmaceutical products. Improper pest control and waste management system can also lead to contamination. Inadequate cleaning and sanitization process can also be a major cause of product contamination.3. HVAC System
HVVC system plays an important role in safeguarding the pharmaceutical products. It helps to minimize the entry of dust particles and microbes into the manufacturing area. Inadequate or faulty HVAC system can cause physical or microbial contamination.4. Material Mix-ups
Improper handling and labeling of pharmaceutical ingredient can cause mix ups during the manufacturing process. Improperly trained warehouse personnel can mix-up materials during sampling or dispensing of the raw material.5. Cleaning Validation
When cleaning validation is not done properly or an unvalidated cleaning method is used to clean the manufacturing equipment, residues of previous product or cleaning agents may cause contamination. The purpose of cleaning validation is to verify that cleaning method is working and no cleaning agent residues are left after cleaning.We can investigate the source of contamination by conducting visual inspection, looking for physical signs of source of contamination or any equipment malfunction. We can also talk to operators and manufacturing staff asking them questions those can help to identify the source. The determination of source of contamination will help us to prevent the reoccurrence of this issue again. Following are the different ways to prevent contamination in pharmaceutical products.
Different Ways to Prevent Contamination in Pharmaceuticals
1. Training Programs
Inadequate training is main cause of contamination in pharmaceutical so proper training major method to prevent the homosexual contamination All personnel are trained in GMP requirements, gowning procedures hygiene and contamination risks during manufacturing.2. Validated Procedures
Every equipment and product have a specific cleaning requirements, therefore it is required to create and validate cleaning procedures for all products manufactured in the facility.3. Environmental Monitoring
HVAC system and environmental monitoring are very useful in controlling the contamination as well as cross contamination during the manufacturing process. HVAC system cleans and recirculate the air and help to minimize the contamination while environmental monitoring helps to identify the microbial contamination.4. Regular Internal Audits
Regular internal audits can help to find the issues and gaps before they cause any significant problem. Internal audits must be done by the experienced personnel of cross functional departments because the same department personnel will not be able to find the actual problems.Contamination is a universal risk in pharmaceutical manufacturing industry. By taking adequate measures, you can minimize the risk of contamination. GMP regulations and written standard operating procedures (SOPs) can also minimize the contamination risk.
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