Cross Contamination

Product contamination in the pharmaceutical industry

6

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

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.

 

  • Materials

-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.

 

Recommendations

  • 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.

 

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