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IntroductionWhat is Microbiology?

What is Pharmaceutical Microbiology?

Importance of Microbiology in the Pharmaceutical Industry

Microbiological Considerations in the Pharmaceutical Industry

The Essentials of Pharmaceutical Microbiology

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Before we get into the details, let's clearly understand the meaning of

terms “Microbiology” and “Pharmaceutical Microbiology”.

As we all know, “Micro” means very small and “biology” is the study of

living things, so microbiology is the study of very small living organisms such

as bacteria, protozoa, fungi and similar organisms that can't be seen with the

naked eye.

What is Microbiology?

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Pharmaceutical microbiology is an applied branch of microbiology that

is responsible for ensuring that medications do not contain harmful levels of

microbes- such as bacteria, yeast and molds.

It mainly focuses on the manufacturing techniques, process controls,

and finished product attributes that limit the harmful effects of

microorganisms on the drug product.

What is PharmaceuticalMicrobiology?

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Pharmaceutical products can save lives and bring back the health of

patients, but what if these products are contaminated?

The presence of microbial contaminant in pharmaceutical products can

reduce or even inactivate the therapeutic activity of the products and has

the potential to adversely affect patients taking the medicines.

Furthermore, the presence of bad bugs in pharmaceutical products can

lead to costly products recalls resulting in financial and image losses, loss of

product sales, decreased customer confidence, and in many cases, legal

proceedings.

Thus, it is important to know the microbial content of all drugs and

medicines, whether they are sterile or non-sterile and to implement strict

microbial controls to ensure that the final products are consistent, safe,

effective and predictable.

Why Microbiology inPharmaceutical Industry?

Patients Company

InfectionsSerious illnessDeath

Products recallsLoss of salesFinancial lossDecreased customer confidenceDamage to company's reputationLegal proceedings

Effects of microbial contamination in pharmaceutical products

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Microbiological operations are an integral part of pharmaceutical

industry and play a significant role in the overall product life cycle.

Development of new drugs - vaccines, antibioticsFermentationMicrobial bioconversions of drugs

Microbiological Testing - Sterlity Testing

Preservation of drugsCold Chain

Aseptic processingSterilization Process validationEnvironmental Monitoring

MicrobiologicalConsiderations in thePharmaceutical Industry

Microbiology- An Integral Part of the Pharmaceutical Industry!

Drug Development

Drug Manufacturing

Quality Control

Storage & Distribution

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Microbial Contamination ofPharmaceutical Products

What is Microbial Contamination?

Sources of Microbial Contaminants

Factors Affecting Microbial Spoilage of Pharmaceutical Products

Prevention and Control of Microbial Contamination

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What is MicrobialContamination?

Microbial contamination is defined as “deterioration of

pharmaceutical products by the contaminant microbes”.

The contaminating microorganisms may cause spoilage of the product

with loss of its therapeutic properties and, if they are pathogenic, serious

infections can arise.

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Sources of MicrobialContaminants

Microorganisms can gain entry into a production process stream from

several sources:

Facility

Sources ofContamination

Personnel

Utilities

Equipment

Process

Materials

Flow of PersonnelMaterial WasteHVAC.

AssemblyCleaningSterilization

Open Vs Closed

Raw materialReusable resin andMembrane filter

WaterGases

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Factors Affecting MicrobialSpoilage of PharmaceuticalProducts

There are many factors affecting microbial spoilage of pharmaceutical

products. These include:

Nutritional factors: Microorganisms utilize many formulation

components as substrates for biosynthesis & growth.

Water: It is the most important cause of the survival and growth of

micro-organisms.

Storage temperature: Spoilage of pharmaceuticals could occur

potentially over the range of about 20°C to 60°C, although it is much less

likely at the extremes.

pH: Micro-organisms grow at neutral pH, therefore acidic or alkaline

formulations are less susceptible to spoilage.

NutritionalFactors

StorageTemperature

Water pH Package Design

The Essentials of Pharmaceutical Microbiology