Microbiology Laboratory Test Methods
MICLAB – METHOD 001 Bioburden Determination
This general test method shall be followed in order to determine total aerobic bioburden. This procedure applies to packaging components such as bottles, tubes, etc., which are used in the manufacture of products at a GMP site. This procedure is also used for determining the bioburden of sampling jars.
MICLAB – METHOD 002 Enumuration of Biological Indicators
This general test method applies to the enumeration of viable spores on spore strips. This procedure will be used to evaluate suitability of spore strips for use in monitoring sterilisation efficacy of autoclaves.
MICLAB – METHOD 003 Membrane Filtration Techniques
This general test method sets out the procedure to be followed for estimating the number of colony forming units (cfu) using the membrane filtration technique. This procedure is applicable only to liquids, which can be efficiently filtered without causing a build-up on the membrane (eg. Listerine, Ora-sed jel) and will be followed to test purified water, rinse water and alcohol.
MICLAB – METHOD 004 Presence or Absence Test of E.Coli
This General Test Method shall be followed in order to determine the presence or absence of E. coli. This procedure applies to all products manufactured at the GMP site and the raw materials used to manufacture those products.
MICLAB – METHOD 005 Method for preparation of Diluent plus 0.1% Tween 80
This document describes the method for preparation of Diluent plus 0.1% Tween 80
MICLAB – METHOD 006 Method of preparation of Hard Water
This document describes the method of preparation of Hard Water.
MICLAB – METHOD 008 Presence of Viable Spore on Spore Strips
This general test method applies to the determination of presence of viable spores on biological indicators (spore strips). This procedure applies to biological indicators which have been subjected to sterilisation.
MICLAB – METHOD 009 Preparation of Malt Extract Agar
This operator instruction describes the method for the preparation of Malt Extract Agar used in the microbiology laboratory.
MICLAB – METHOD 010 Preparation of Asparagine Broth
This document describes the method for preparation of Asparagine Broth.
MICLAB – METHOD 011 Preparation of Bacillus spp Spore Suspension
This procedure details instructions for the preparation of Bacillus spp spore suspension.
MICLAB – METHOD 012 Presence or Absence Test of Clostridium Perfringens
This general test method shall be followed in order to determine the presence or absence of Clostridium perfringens in raw materials and finished products.
MICLAB – METHOD 013 Presence or Absence Test of Indicator Organisms
This general test method shall be followed in order to determine the presence or absence of indicator organisms such as Pseudomonas spp., Coliforms (e.g. Klebsiella spp., Enterobacter spp.) and coagulase positive Staphylococcus spp. This general test method is also followed when screening for objectionable organisms in order to determine the presence or absence of any gram negative rod. This procedure applies to products manufactured at GMP Manufacturing site as well as raw materials used to manufacture those products. This procedure covers tests for objectionable and deleterious organisms.
MICLAB – METHOD 014 Presence or Absence Test of Salmonella SPP
This general test method shall be followed in order to determine the presence or absence of Salmonella spp. This procedure applies to all products manufactured at a GMP site and the raw materials used to manufacture those products.
MICLAB – METHOD 015 Microbiological Method for The Testing of Disinfectant
This document describes the method for the testing of disinfectants.
MICLAB – METHOD 016 Maintenance of Culture Collection for Aseptic Practices in the Laborator
This document deals with the correct means of maintaining a culture collection with an emphasis on aseptic practices in the laboratory.
MICLAB – METHOD 017 Method for Preparation of DNase Agar (Oxoid CM321)
This document describes the method for preparation of DNase Agar (Oxoid CM321).
MICLAB – METHOD 018 Procedure for maintenance of IQ 2000 MKII Precision Peristaltic Dispenser
This procedure describes how to use and maintain the IQ 2000 MKII Precision Peristaltic Dispenser and the Perimatic Premier Dispenser.
MICLAB – METHOD 019 Validation of Microbiological Test Methods
This general test method applies to the determination of microbiological test method soundness. This procedure is applicable to finished products and raw materials. Test Method Validation is to be performed when any of the following occur: i) New formulation of a finished product, ii) Change of active raw material in a product, iii) Change in the site of manufacture of a product, iv) Use of a new brand of microbiological media.
MICLAB – METHOD 020 Procedure for use and maintenance of Laminar Flow and the Biohazard Cabinet
This document provides instructions for the use and maintenance of the Laminar Flow Cabinet and the Biohazard Cabinet.
MICLAB – METHOD 021 Preparation of CFC agar
This document describes the method for preparation of CFC agar.
MICLAB – METHOD 022 Method for preparation of Pseudomonas Agar Base (Oxoid CM 559
This procedure describes the method for preparation of Pseudomonas Agar Base (Oxoid CM 559).
MICLAB – METHOD 023 Preparation of Letheen Broth + 2% Lecithin and 4% Tween
This procedure describes the method for preparation of Letheen Broth + 2% Lecithin and 4% Tween (AMYL AM89, DIFCO 268110).
MICLAB – METHOD 024 Preparation of CLED medium (Oxoid CM 301)
This document describes the method for preparation of CLED medium (Oxoid CM 301). CLED medium supports the growth of all potential pathogens (eg. Salmonella) giving good colonial differentiation and clear diagnostic characteristics.
MICLAB – METHOD 025 Preparation of MacConkey Agar No. 3 (Oxoid CM115)
This document describes the method of preparation of MacConkey Agar No. 3 (Oxoid CM115). This selective medium is used for differentiation between coliforms and non-lactose fermenters.
MICLAB – METHOD 026 Preparation of double strength Lauryl Tryptose Broth – Oxoid CM45
This document describes the method for preparation of double strength Lauryl Tryptose Broth (Oxoid CM451). Lauryl Tryptose Broth is used to determine the presence of coliforms.
MICLAB – METHOD 027 Procedure for the use and maintenance of Labec Incubators
This document describes the procedure for the use and maintenance of Labec Incubators. Labec Incubators are used in the testing of finished products, raw materials, environmental monitoring and process water.
MICLAB – METHOD 028 Identification of bacterial isolates and contaminants
This procedure describes the necessary steps required in the identification of bacterial isolates and contaminants. This procedure is used to profile and identify bacterial isolates/contaminants obtained from microbiological tests performed in the microbiology lab.
MICLAB – METHOD 029 Determination of Waterbath and Incubator Temperature Profiles
This operator instruction is applicable to all QC laboratory personnel involved in performing incubator temperature profiles.
MICLAB – METHOD 030 Induction of new analysts into the chemistry and microbiology laboratories
The purpose of this Operator Instruction is to (define the procedure) to introduce new employees to the Chemistry or Microbiology Laboratories. This Operator Instruction applies to the induction of new analysts to the Chemical and Microbiology Laboratories.
MICLAB – METHOD 031 Method of preparation of Bacteriological Peptone (Oxide-L34)
This document describes the method of preparation of Bacteriological Peptone (Oxide L34). Bacteriological peptone (0.1%) is used as a high quality diluent for microbiology testing.
MICLAB – METHOD 032 Yeast and mould count in microbilogy laboratory
This general test method shall be followed in order to determine the total yeast and mould count. This procedure applies to manufactured products, raw materials used in manufacture and environmental samples at a Microbiology Laboratory of GMP site.
MICLAB – METHOD 033 Total Microbial Plate Count
This general test method shall be followed in order to determine the total viable bacterial count (Total Plate Count). This procedure applies to all finished products, raw materials, preservative efficacy and environmental testing.
Note: Total Plate Count also refers to the following terms: Total Aerobic Plate Count, Total Aerobic Viable Count and Standard Plate Count.