This slide is uploaded to help future trainees to help them prepare for their Presentation effectively. uploaded by Dr. Nasir Hussein

1. PREPARED BY:
Abdunasir Hussein Ibrahim
North South University
Prepared for :
Labonnya Haider
QA Department
Incepta Pharmaceuticals Ltd.

2. Contamination Control in Pharmaceuticals

3. Introduction
Definition:
Contamination can be defined as the introduction or presence of
unwanted impurities/ materials such as dust and particles during the
manufacturing and transportation time or during storage.
Cross contamination can be defined as the introduction of the
starting/raw material, intermediate product or finished product with
another starting material, intermediate product or finished
product.(WHO)

6. Types of Contamination
 The most common types of contaminants
include
a) Physical contamination. Examples:
fiber material, particles, chips from
your pill press tooling.
b) Chemical contamination. Examples:
vapor, gasses, moisture, molecules.
c) Biological contamination. Examples:
fungus, bacteria, virus

7. Contaminants can gain entry into a production process stream from
several sources such as:-
• Personnel,
• Poor facility design,
• Incoming ventilation air,
• Machinery and other equipment for production,
• Raw material and semi-finished material,
• Packaging material, Utilities,
• Different media used in the production process as well as for cleaning
and Cleanroom clothing.

9. Steps taken to Prevent Contamination in Pharmaceuticals

10. Premises and Design of Building
 Good design of facilities &services equipped with maximum protection
eliminates risk of the entry contaminants into the manufacturing area.
 Entry of unauthorized person should be prevented in production, packing
and quality control areas and logical material flow must be developed.
 Interior surfaces of walls, floor and ceiling should be smooth, free from
cracks and open joints, should not shed paint particulate matter and should
permit easy and effective cleaning.
 Ventilation and light points should be designed to avoid creation of
recesses which are difficult to clean.

11.  Should have smooth surfaces free from pitting.
 Contact surfaces should be inert, should not be additive or absorptive.
 Use dedicated equipments which are easy to clean.
 Equipment cleaning aids like bristles, brushes, shedding clothes, that may
raise dust or generate contamination should not be used.
 Ensure that all materials of previous product manufactured are removed
and after cleaning there should be no residual cleaning agent left behind.
 Repair and maintenance operations should not present any hazard to the
quality of the product. Wrap the cleaned equipment with polythene bags
until use.

12.  All personnel prior to and during employment as
appropriate should undergo health examination.
 Personnel should wear clean body coverings
appropriate to the duties they perform.
 Direct contact should be avoided between the operator’s
hand and starting materials, primary packing materials
and intermediate and finished products.
 Appropriate personnel protective equipments (PPE’s)
should be used wherever applicable.
People

13. To reduce air as carrier of
contaminants:
• Control air flow through Air
Handling Unit (AHUs)
• Use of air locks
• Installation of HEPA filters
• Ultra-Low Particulate Air
Air Control

14. •Use appropriate machineries to Loading and unloading
•Dispense one material at a time to prevent
•sampling must be taken in a room that has a suitable air control
system to prevent contamination through airflow
•Regularly check if the cleaning process is effective
•Properly design airflow system to prevent airflow contamination
•Dispensing stations should have proper dust extraction system
•Avoid charging two materials at a time
•Avoid unloading different materials for different batches
simultaneously.
Raw Materials

16. During production
•Dispensing stations for the materials should have proper dust
extraction system and air conditioning system.
•Regularly check equipment for wear and tear to prevent any
compromise to its integrity
•Cleaning must be effectively carried out.
•Do not return used samples to their original containers
•Line clearance must be observed during product changeover
•Ensure proper cleaning of equipment to prevent any biological
contamination

18. https://www.lfatabletpresses.com/articles/contamination-causes-prevention-pharmaceutical-
industry
https://www.slideshare.net/jitendrajagtap1986/cross-contamination-jjj
https://www.pharmaguideline.com/2011/09/prevention-of-cross-contamination-in.html
https://learnaboutgmp.com/aseptic-techniques/prevention-of-contamination-and-cross-
contamination-in-pharmaceutical-dosage-forms/
https://www.airchecklab.com/aircheck-academy/compressed-air-in-manufacturing/sources-
of-contamination/sources-of-contamination-in-manufacturing/
https://www.pharmaguideline.com/2013/08/pharmaceutical-contamination-and-its.html
https://www.lfatabletpresses.com/articles/preventing-cross-contamination-in-pharmaceutical-
production-process
https://www.pharmaguideline.com/2011/09/prevention-of-cross-contamination-in.html
https://slideplayer.com/slide/1574985/