Pharmaceutical Microbiology Lecture Notes #1

Example of Pharmaceuticals

Lotions, Cream, Cosmetics and eyes solutions,cough syrups and vaccines are all examples of pharmaceutical products

Impact of Microbes

Microbes help to create many Health/ Pharmaceutical products such As Antibiotics, Vitamins, Vaccines and Biopharmaceuticals. It is harvested from Bacteria Culture

Purpose of Bio reactors

The Bioreactors are used in The process of nudtsircal fermentation to assist growth of continuous and batch cultures of bacteria organisms.

Testing of drug products

Microbes are often using for test drug products they are known as bioassay. and example of an Assay is Vitamin potency assay that uses a microbe thats requires a specific vitamin to gorwn,and cannot make it itself.

Issues rooted from microbes

When microbes are mishandled they become contaminates thats can be very severe. Effects include reactions, infections, Toxicity and death to the consumer. As well could cause Product deterioration causing loss of potency,alteration of a activity. Could affect a Company spending money to fix the issue

Important characteristics of testing a drug product ??

Revolves around numbers through the quantitative testing -quantity of microbes in Organisms. Along with the bacteria identity If an organisms are pathogenic. As well what is the basis of the contamination of the source.

Products guidelines and sources of publications

Within Canada They must follow Standrards,LImits and Guidelines withing canada the manufactures must follow several publication such as USP( United states pharmacopeial), NF (national formulary),BP (British Pharmacopeia), CF(Canadian Formulary).

Purpose of the Publications Guidelines

To outline The information regarding the products in refenec eof a product chemstry though purity and potency as well as Microbiological purity-the allowed and acceptable limits of microbes within the Medicine. Also Lab Testing must follow the respected methods in the setting of pharmaceutical microbiology laboratories

Testing with Standardized Microbes

It is known as the tests being applied for certain organisms. It usually work in parts of a ATCC microbe Each thats been assigned with a number.

What is The ATCC

Known as a culture Deposist system in the united states that they store Bacteria,fungi,viruses.Has a distinct characteristics for each of the Cultures and its known to be Purchased by laboratories and researchers.

The American Type Culture Collection

It is a process that ensures thats each test is standardized. WHile using the USP will specify which particular microbe is to be used for a particular Assay. As well The specific procedures for the stock culture maintenance.

Products that must be sterile

Bandages. The dressing for wounds. Ophthalmic solutions. Parenteral . Must have a Sterility test must be performed. As well with the TOtal exlcusion must be Sterlie and have no organismes allowed at all

Important areas of The Manufacturing Facilities that’s must be Monitored for contamination

In industrial setting the Air is known to be a potential source of contamination as well as the work surfaces can be a major source of contaminations.

The disinfectants and sanitizers thats are place to control and eliminate contaminating microbes.