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Pharmaceutical Contamination Control


Difffcerent types of pharmaceutical contaminations, causes and control of contamination in pharmaceutical production during manufacturing
Introduction of undesired dust or dirt into or on to during manufacturing, packing and transportation is called as contamination and contaminant is the unwanted element being introduced in the system. It is any substance which has an adverse effect on the product or process.

Pharmaceutical Contamination ControlTYPES: Contamination is of three types depends on mode by which they can damage. They are
1. Physical Contamination. Eg. Particles, fiber etc.
2. Chemical Contamination. Eg. Moisture, Vapors, Molecule, Gases etc.
3. Biological Contamination. Eg. Bacteria, Virus, Fungus etc.

CROSS CONTAMINATION: 

Unwanted introduction of one drug substance during manufacturing to the other drug substance.
Example for Physical Pharmaceutical Contamination: A leakage from oil seal of reactor may contaminate the product being processed inside the reactor.

Example for Chemical Pharmaceutical Contamination: In case the recovered solvent is stored in a drum of other solvents, which was not cleaned properly may contaminate the recovered solvent. The contaminated solvent if used in the process may spoil the product by giving the additional impurity.

In case a product is exposed in an uncontrolled environment of high relative humidity, may increase the moisture content of the product.

Example for Biological Pharmaceutical Contamination: If powder processing equipment is left undried after cleaning with water may proliferate the microbes in the equipment. If the same contaminated equipment used for processing, may contaminate the powder microbiologically.

BIOLOGICAL CONTAMINATION IS DUE TO

● Improper sanitation of hands
● Improper Gowning
● Use of biologically contaminated water for cleaning of equipment.
● Open lesions
● Suffering from Infectious diseases.

PREVENTION OF PHARMACEUTICAL CONTAMINATION:

● Identify the contaminant.
● Anticipate the contaminant.
● Prevent Ingress.
● Facilitate Egress.
● Minimize the Internal generation
● Control residual contamination

ELIMINATING SOURCES: 

Like Shredding cloth, previously processed material

ELIMINATING THE CONTAMINATION TRANSPORTER

● Reducing human intervention.
● Controlling the use of equipment for different product.
● Controlling the use of air.
● Controlling the use of water.

TO REDUCE HUMAN AS TRANSPORTER:

● Fallow gowning.
● Proper gowning in clean area where the product is exposed for a longer time.

TO REDUCE WATER AS TRANSPORTER: 

Water is commonly used pharmaceutical ingredient and one of the biggest sources of cross contamination.
● Examples of water borne contamination
• Particulate: Presence of minerals like Ca, Mg etc…
• Pathogens : Escherichia coli, salmonella, pseudomonas etc…
● Prevention:
• Adequate filtration devices
Reverse osmosis/ultra filtration/distillation
UV treatment.

TO REDUCE AIR AS TRANSPORTER: 

Air as a constituent of environment, is prevent universally in work area
● Examples of air borne contamination
• Particulate contamination-dust, product contamination.
• Biological contamination.
● Prevention:
• Control on flow of air through Air Handling Units (AHUs)
• Air locks
• Installing High Efficiency Particulate Air (HEPA)
• Ultra Low Particulate Air (ULPA)

Related: Prevention of Cross- contamination by HVAC



TIPS TO PREVENT PHARMACEUTICAL CONTAMINATION:

● Sample only one material at a time
● Sampling in a segregated cubicle/booth fitted with suitable air control systems.
● Use of dedicated tools for sampling
● Dispensing stations must be equipped with suitable dust extraction system.
● All containers packaged must be effectively cleaned before these are admitted to the storage area.
● Evolve and follow suitable equipment cleaning procedures. Periodically validate them to confirm the effectiveness
● Regularly check and confirm the integrity of oil seals.
● Air supply systems for the production and dispensing areas must be designed to avoid contamination into the airflow (or) to the manufacturing areas.
● Do not return the samples drawn for in-process control to original containers.
● To the extent possible, material during process should be unidirectional.
● Regularly monitor the quality of water, particularly for microbial contamination.
● Simultaneous charging of raw materials for two different batches, two different stages and two different products should be avoided.
● Simultaneous unloading of materials for two different batches, two different stages and two different products should be avoided.
Line clearance must be taken for the product change over. During change over single individual impurity is not more than 0.1% (1000 PPM). Total impurity is not more than 0.5% (5000 PPM).

Also see: HVAC System Validation


Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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