Validation Cross

Contamination

Group 10
1. ZOLLA VEBRIANTI S (1311012004)
2. ELSHA GUSFIANDA (1311012011)
3. DIANTY DWI WAHYUNI (1311012017)
4. COSMAS BAFARESO Z (1311012019)
5. YUDI NOFPRIMADANA (1311012020)

What is validation
Validation is a documented act of providing that any procedure,
process, equipment, material, activity or system, actually leads to
the expected result.
(Sandhya, et al, 2015)

What is cross contamination?

Cross contamination occurs when harmful bacteria are transferred from
contaminated food to uncontaminated food.
(Cooksafe, 2012)
Pharmaceutical product cross-contamination refers to the process by
which foreign chemical, microbial, or physical substances are
unintentionally transferred from one substance or object to medicines
with harmful effects that might affect the purity and quality of the
pharmaceutical products leading to health impacts on human and animal
users.
(mathias, 2000)

How does Cross Contamination occur?

1. By Direct Cross Contamination contact between raw food and
ready-to-eat food during transport, storage or preparation
2. By Indirect Cross Contamination - spread of bacteria from raw
food to ready-to-eat food via food handlers, equipment or surfaces.
For example, indirect cross contamination can occur via refrigerator
door handles, knives, chopping boards, work surfaces, chefs cloths
or cleaning cloths
(Cooksafe, 2012)

INDUSTRIAL PHARMACY PRACTICES

The main sources of cross-contamination in drug manufacturing
are human beings, air, equipment, water, and raw materials.
(mathias, 2000)
Human beings carry normal flora such as Staphylococcus aureus
and may serve as the main source of microbial crosscontamination
during manufacturing of pharmaceuticals. (mathias, 2000)

Cont..
Air carries a lot of materials both organic and nonorganic which may be
potential contaminants in pharmaceutical manufacturing. To avoid air
contamination during manufacturing it is a requirement that pharmaceutical
industries provide appropriately designed airlocks, pressure differentials, and
air supply extraction systems.
(mathias, 2000)
Pipes used for conveying distilled or de-ionized water and, where
appropriate, other water pipes should be sanitized and stored according to
written procedures that detail the action limits for microbiological
contamination and the measures to be taken. (mathias, 2000)

Attention !!
Cleaning of:

Pipelines

Valves

Joints

Bearings

Blanked-off ends

Drying

Milling

Sieving

Blending Equipment

(mathias, 2000)

Cont
Mix-up
Cross contamination is caused by human error (incorrect API, use of contaminated
equipment)
Retention
Material which is left from the previous process due to failure or inadequate cleaning
Mechanical transfer or carry over
Transfer by mechanical means of contaminants from non-product contacts part, transfer
system etc.
Airborne precipitation
The risk of one product in airborne suspension contaminating another product
(Morvai,2011)

RECOMMENDATIONS
A training program for health care workers about the risk of crosscontamination in hospitals and safe ways of preparing solutions for
parenteral use should be put in place.
Conducting regular training for pharmaceutical dispensers on good
dispensing practices.
Alcohol hand hygiene in hospitals, observance of the
manufacturer's recommendations and appropriate storage conditions
for medications should be insisted upon.
(mathias, 2000)

Cont
To reduce the risk of medicine cross-contamination, government
and stakeholders should increase the number of well-trained
pharmaceutical human resources.
More studies which will cover many parameters on medicine crosscontamination should be conducted to ascertain the problem and
address the situation in a more scientific way
(mathias, 2000)

Conclusion
Validation of equipment cleaning procedures should be practiced
in pharmaceutical industries to prevent cross-contamination of
drug products. The most important benefit of conducting
equipment cleaning validation is to identify and correct the
potential problems previously unsuspected which could
compromise the safety, efficacy and quality of subsequent batches
of drug product produced within the equipment.
(Rajkumar,2011)

Daftar pustaka
Mathias.2000. Pharmaceutical product cross-contamination:
industrial and clinical pharmacy practice. Muhimbili University of
Health and Allied Sciences
Cooksafe. 2012. House rules cross contamination prevention.
Food Safety Assurance System
Rajkumar. 2011. Prevention Of Contamination And Cross
-Contamination In Pharmaceutical Dosage Forms
Morvai,magdolna. 2011. Risk Management in the Pharma
Industry. Hungary. TEVA Pharmaceutical Works PLC