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Cross Contamination

Group 3
Maghfira Putri Ilham (1411011025)
Winda Astuti (1411011029)
Farah Putrizeti (1411011036)
Mutia Hardi Saputri (1411011041)
Forence Clay Mora Sirait (1411011050)
Introduction
Manufacturing medicinal products involves a series of
processing steps using various equipment and ancillary
systems within a facility.
Each step/equipment/system can pose a risk of
contamination.
Contamination is the undesired introduction of impurities
(of a chemical or microbiological nature) or of foreign
matter, into or onto a starting material or intermediate or
API during:
- production
- sampling
- packaging or repackaging
- storage or transport.
(Pharmout,2016)
Cross-contamination is the contamination of a
starting material, intermediate or finished
product with another starting material or
product.
Manufacturers must have processes in place, to
not only avoid contamination scenarios but also
provide documented evidence that
contamination has not occurred.
The reasons for contamination and cross-
contamination can vary and be caused by
technical or deficiencies within the organisation.
(Pharmout,2016)
Sources of Contamination

(Pharmout,2016)
Design Opportunities
The design of a facility, its Heating Ventilation
and Air Conditioning (HVAC) system and
equipment is the first and critical step in
preventing contamination and cross-
contamination.

(Powell, et.al. 2014)


(Powell, et.al. 2014)
Personal and Procedures
Manufacturing Process
To minimize risk of contamination and cross-contamination, the
following should be considered:
Dedicate the facility to the manufacture of a single formulation of
product.
Manufacture products in a campaign, with the appropriately
qualified cleaning processes and checks performed in-between
batches to minimise the amount of product changeovers.
Utilise a closed manufacturing system. This is where the product is
not exposed to the immediate room environment (and vice versa).
Perform an area line clearance according to approved procedures
following each
cleaning process and between each batch/campaign.
Zone the facility.
Use Cleaning Status labelling on all equipment and materials used
within the manufacturing facility
(Powell, et.al. 2014)
Personnel Training and Clothing
Training is key in instilling good practices in
personnel, that is: knowing that each and
every person has a responsibility to consumer
health.
Each employee must understand their role
and responsibilities, which should be clearly
outlined in a job description.

(Powell, et.al. 2014)


(Powell, et.al. 2014)
Cleaning Procedure
Cleaning equipment
Labels should be attached to each piece of equipment
to clearly state the cleaning status
Ensure that operators are trained
Ensure that utilities and services have been testes and
monitored routinely
Do not use clening aids such as brities, brushes, and
particle-shading clothes for manual cleaning of
equipment
Document the cleaning status of each equipment in
logbooks

(Powell, et.al. 2014)


General housekeeping
Cleaning and housekeeping of all areas within
a facility should be performed routoinely. This
includes floors, ceilings, walls, work surfaces
Empty bins regulary
Clean any spills immadiately
Remove all unnecessary equipment and store
appropriately

(Powell, et.al. 2014)


References
PharmOut. 2016. White paper: Prevention of
contamination and Cross-Contamination in
Medical Manufacturing Facilities.
www.pharmout.net
Powell, David, et.al. 2014. Cross-Contamination
in Drug Manufacturing: The Regulatory
Trends. Fierce Markets Custom Publishing

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