Impact of Contamination, cross-contamination & mix-ups in Pharmaceutical

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Contamination, cross-contamination, and mix-ups are the factors that reduce the quality of a drug product. If the drug is contaminated ultimately it will affect the reputation of the organization, the value of the organization may get impacted.
     
      This article will be the best article to understand the contamination, cross-contamination, and mix-ups of formulation and their definition.

Contamination is a introduction of undesired impurities (such as chemical, microbiological or foreign matter) at different stage level of manufacturing, production, sampling, packaging, storage or transportation into the drug product.

 

Definition of cross-contamination in the pharmaceutical industry:

 

Cross-contamination is a contamination of starting material, intermediate or finished product with another starting material or a product during manufacturing process.

 

 

Sources of cross-contamination in the pharmaceutical industry:

 

The following are some of the sources of cross-contamination in the pharmaceutical industry.
 
1. Premises
2. Machine (Equipment/instrument)
3. Man
4. Processing 
5. Utilities and services
6. Clothing

 

Definition of Mix-ups in the pharmaceutical industry:

 

Mix-ups is inadvertently mixing of one thing to another. It is a mistake that results from taking one thing to be other. 

 
Reason for mix-ups:
 
Improper segregation of labels, same instruments used for different products, Handling of multiple products in one area is the reason for mix-ups.
 

Types of Contamination in the pharmaceutical industry:

 Basically, three types of contamination can be possible in the pharmaceutical industry.
 
1. Microbial 
2. Chemical 
3. Physical 
 
1. Microbial contamination is due to bacteria, yeast, moulds, and parasites.
 

2. Chemical contamination is due to API, intermediate, chemicals, and additives.

3. Physical contamination is due to Hairs, glass, paper, and real particles. 

This is the most common contamination observed in the pharmaceutical industry. So many market-compliant are filed due to physical contamination.

 

Sources of Contamination in the Pharmaceutical industry:

 Contamination can be possible with five different sources. These are the major sources of contamination as follows:
 
1. Man
2. Air
3. Water
4. Equipment
5. Material
 

1. Man:

 
If people will not follow good hygiene practices or correct behavioral practices in the cleanroom or change room, it can be a source of contamination. Man is the primary source of contamination. 
 

2. Air:

 
If the HEPA filters are not working due to damage or the HVAC system is not working properly then it can increase the contamination chances.
 

3. Water:

 
Improper filtration or sanitation or stagnant water or leakage in the water distribution system can increase the chances of microbial contamination. In stagnant water, there are chances of growth of microbial fungi.
 

4. Equipment:

 
If Equipment is not cleaned properly, observed erosion due to fraction can increase the chances of contamination. 
 

5. Material:

 
Improper handling of drugs, like API, excipient, or packing material can be a source of contamination. While dispensing or shifting of material if precaution not taken, then it will be big contamination that may be up to batch discard.

 

Impact of Cross-contamination and Mix-ups

1. Loss of reputation
2. Show cause notice
3. Loss of business
4. Warning letter
5. Production ban
6. Closure of premises also.
 

How to Prevent Cross-contamination in Pharmaceuticals?

There are multiple precautionary ways to prevent cross-contamination;

General Precaution

Compressed Air

Steam

Utility

Clothing

Sanitization and cleaning

What are the general precaution to perform Cleaning

  1. Before starting the manufacturing of drug product need to do line clearance and record it.
  2. Avoid more production at a time, only one product at a time is the best practice.
  3. Ensure to non-availability of previously manufactured product traces.
  4. Ensure proper line cleaning.
  5. Check the containers visually for cleanliness.
  6. Ensure validated systems are being in use.
  7. Avoid bare handling of the drug products.
  8. Clean and unclean material should be in separate places and shall be labeled.
  9. Do not keep the sample return to its original container.

Compressed Air precaution:

  1. Regularly check filters for cleanliness
  2. Regularly check filter integrity
  3. Use filtered air in the manufacturing area

Steam Precaution:

  1. Steam is useful for cleaning, use a steam generator for cleaning
  2. Steam should be free from any foreign matters.
  3. Steam should be free from unknown matters which affect the production.
  4. Steam should be in proper condition, improper steam generator can produce contaminated steam.

Utility Precaution:

  1. Ensure the reliable water source for the manufacturing of drug products.
  2. Ensure the proper microbiological and chemical levels.
  3. Regularly do the water testing for microbial growth.
  4. The water supply should be with proper channels.

Clothing Precautions:

  1. The person should wear proper clean dress and footwear
  2. Wash regularly aprons and linens.
  3. Regularly wash hands after using washrooms.
  4. Change clothing after every break
  5. Clothing in such way that covers full body
  6. Use separate cloths for every department
  7. Avoid exposure of own clothing and footwear

Sanitizing and cleaning precautions:

  1. Ensure sanitization of every area of manufacturing
  2. If spillage happened of any of the material batches shall be discarded
  3. Sanitize the equipment and label it as clean equipment.
  4. Airlocks should be in the place wherever required
  5. Proper hygienic practice shall be followed in the unit
  6. Pest control chemicals, cleaning agents, shall be away from the manufacturing area.

Read more:

What is data integrity and role of Alcoa Plus

cGMP Principle in the Pharmaceutical Industry

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