Product contamination in the pharmaceutical industry
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, may have a potential to be contaminated with micro-organisms or other foreign particles such as metals. Producing medicinal products requires several manufacturing steps using various types of equipment and supporting systems within a facility. Failure to provide these measures can lead to contaminants gaining entry into a production process from several different sources.
Main sources of product contamination in pharmaceutical industry.
Personnel can be a potential source of microbiological contamination and a vector for other contaminants because of the following reasons:
-Lack of training and access of unauthorised personnel.
-Inadequate cleanliness and malpractices in the storage and processing area.
-Direct contact between the operator’s hands and the starting materials, primary packaging material and bulk product.
- Buildings and facility
The main reasons for contamination due to facilities and pharmaceutical buildings include:
–Insufficient and inadequate organisation of space.
–Lack of a filtration system.
–Poorly executed ventilation and lighting.
-Handling and storage of pharmaceutical product mistakes can cause mix-ups and selection errors.
-Storage and handling mistakes causing mix-ups or selection errors.
-Materials can be contaminated with micro-organisms or other chemicals.
-Degradation from exposure to harsh environmental conditions.
-Improper labelling, sampling and testing.
Other sources include equipment and utensils used in processing, holding, transferring and packaging of a pharmaceutical product; heat, ventilation and air conditioning (HVAC) system and manufacturing processes.
Preventative measures for product contamination
- The facility must be of suitable size and be spacious for all the equipment.
- Careful regulation of temperature and airflow.
- Use of water that is microbiologically controlled and monitored.
- Use of equipment made of inert materials.
- Work on smooth surfaces for effective cleaning.
- Airborne contaminants must be removed through controlled airflow.
- Access to production areas must be regulated.
- All workers must wear clean, protective garments.
- Regular training should be provided for un-automated methods.
Product contamination does not only have an effect on manufacturing companies and pharmaceutical industries. There are also socio-economic repercussions.
Social effects of contamination
Cross-contaminated medicines weaken the relationship between patients and healthcare givers, especially in events of drug-resistance and treatment failure.
These effects may include:
- Loss of trust in pharmacists and medicine.
- Fear on patients/clients on drug therapy.
- Economic effect such as losing a client.
- Training programs for health-care workers about the risk of product contamination in hospitals and safe ways of preparing solutions for parenteral use should be put in place.
- Hand sanitisers and appropriate storage conditions for medications should be insisted upon.
- Proper counselling of patients on the proper use of medicines and proper storage of medicines in homes should be provided on dispensing by pharmacists.
- To reduce the risk of medicine product contamination, government and stakeholders should increase the number of well-trained pharmaceutical human resources.
- More studies which will cover many parameters on medicine product contamination should be conducted to ascertain the problem and address the situation in a more scientific manners.
- Pharmacists should focus more on clinical practice, pharmaceutical care of patients and specialisation in clinical pharmacy to save patients from experiencing this problem.