Prepared Media Products (READY TO USE (RTU) CULTURE MEDIA)

Prepared Media Products ( READY TO USE (RTU)  CULTURE MEDIA ) use for Environmental Monitoring, to check microbial load and testing of finished good

PREPARED MEDIA PRODUCTS

Prepared media products are ideal for environmental monitoring in the pharmaceutical industry. These  Prepared Media products undergo quantitative quality control testing, using a low-dose inoculum to ensure optimum performance.

Micromaster has developed a wide range of superior quality, prepared culture media products for this purpose. which are ideal for environmental monitoring in the pharmaceutical industry.

Many Pharmaceutical products cannot be terminally sterilized so they must be manufactured in designated clean rooms. Such clean rooms require effective environmental control systems. To asset level of process control, Environmental monitoring is used in the pharmaceutical industry.

To determine the microbial load in a clean area, local ALERT and ACTION levels must be determined. These levels should reflect the capability of the environment being monitored. If results are approaching an alert level, it means there is a deterioration in control, which can be corrected before the product is at risk. Upon exceeding a threshold, a thorough investigation must be conducted. Furthermore, the data generated by monitoring can be used to identify trends and changes in established microbiological patterns, which can help identify potential problem areas and anticipate new issues.

The methods used in environmental monitoring include air sampling (using automated air samplers and passively using settle plates), surface sampling (using contact plates or swabs) and personnel monitoring.

As a leading manufacturer of superior quality prepared culture media products, Micromaster has developed a wide range of products particularly suited to the pharmaceutical industry for environmental monitoring. We offer 90mm settle plates and contact plates, Polyester Foam Swab, Saline with swabs for area validation, Stickers to avoid particle load in  cleanroom, for use in environmental monitoring 

A variety of Culture media are available like Tryptone Soya Agar, a general-purpose medium, as well as Sabouraud Dextrose Agar, used primarily for growing yeasts and molds. Both are available standard, with or without neutralisers. Soyabean casein digest agar (SCDA) , Potato dextrose Agar, there are some selective ready to use (RTU) plates like, MacConkey agar, Cetrimide Agar, XLD Agar, Mannitol salt agar plates etc. Plates are triple-wrapped and gamma-irradiated, with transparent packaging that helps maintain the products at their best.

As a well-established and reputable company, Micromaster’s Prepared Media products deliver all the assurances. Quantitative quality control is performed on all products using a low-dose inoculum to ensure optimum performance. The specification of all products can be provided. A certificate of origin and a quantitative analysis certificate of analysis are available for each batch.

Our Expertise

Non-breathable packaging system

Longer shelf life, more stability and assured sterility.

Automated production system as per cGMP

Contamination free. Avoids extra effortsin the documentation.

Unique identification with readable and scannable QR code /Barcode

Complete traceability, system driven stock,and paperless work which saves time.

OUR Prepared Media PRODUCTS​

Ready to use (RTU) Solid Bottle Media
Ready to use (RTU) Liquid bottle media
Ready to use (RTU) Liquid Bottle Media
Ready to use (RTU) Plates
Ready to use (RTU) Plates
Saline with Swab
Saline with Swab

FREQUENTLY ASKED QUESTIONS

Microbiological culture media are used for the cultivation, isolation and identification of microorganisms – bacteria, yeast, molds, and fungi – derived from a variety of sources such as environmental samples, food, water and beverages, animal foods, cosmetic, pharmaceutical or clinical samples.

The culture media are designed to guarantee the viability of isolated microorganisms and are used for the enrichment of bacteria to acquire a sufficient amount of cells for further examination.

Microbiological culture media are defined according to ISO 11133-1 Guidelines and contain a large variety of ingredients to support the luxuriant cultivation of microorganisms:

    • Nutrients (e. g. Biological extracts, Digests of proteins)
    • Source of energy (e. g. Glucose)
    • Salts for maintaining adequate osmolarity (e.g. NaCl)
    • Enrichments (essential ingredients for auxotrophic or fastidious microorganisms)
    • Antioxidants and neutralizing agents against toxic substances like disinfectants (e. g. blood, coal, letheen)
    • Reducing agents to remove oxygen from media and maintain anaerobic or microaerophilic culture conditions
    • Indicator substances which indicate pH-shifts or cha nge of the redox state
    • Buffer for pH-regulation (e. g. potassium and sodium phosphates)
    • Chromogenic or fluorogenic nutrients, which are hydrolized by the microorganism and release a colored or flourescent hydrolysis product as indicator.
    • Selective agents to suppress the growth of unwanted microorganisms (e.g. chemicals, antibiotics, fungistatic agents)
    • Neutralizing agents for antibiotics or disinfectants (e.g. letheen, polysorbate) Solidifying agents (e.g. agar, gelatine) Water

Suitable production controls and sterilization conditions as well as a comprehensive quality control system are followed to assure reliable product stability.

Stock cultures and Passaging

American Type Culture Collection (ATCC®) or other reference culture collections provide test strains for growth promotion tests. Prior to preparing stock cultures, strain identity and homogeneity needs to be determined by the Quality Control Department.

At Micromaster : To prepare stock cultures, strains are resuspended in a suitable culture medium. This suspension is spread on a solid medium (e.g. Tryptic Soya Agar) to obtain single colonies. These are resuspended again in 20% sterile Glycerol broth. ‘N’ number of Seed Lot Cultures are created by aliquoting in 2ml amounts in sterile eppendorf vials / cryo vials and stored at temperatures below -20oC.

This procedure allows removing one vial at a time without thawing the stock culture (Passage-1). If desired, Master Cultures & Working cultures can be prepared & maintained for ease of use.

According to the Pharmacopeial procedure a test strain should be sub-cultured only a limited number of times before usage to obtain reliable quantitative results. Therefore a second culture (Passage -2) from aliquoted vials is prepared, from which vials can be removed continuously as per requirement to be cultured on solid media (sufficient for one year). From the cultures of Passage-3 or 4, fresh over night cultures are prepared in suitable broth before being employed in growth promotion testing.

A Schematic guide for use of reference cultures is given below. Specified concentrations of the test strains are required to determine growth promoting properties (< 100 cfu), growth inhibition (> 1000 cfu) and indicative properties (< 100 cfu) in most microbial enumeration tests, in tests for specified microorganisms, and in sterility testing. These defined suspensions are simply prepared by serial dilutions in sterile saline or sodium chloride peptone buffer according to the Pharmacopeias.

Preparation of spore suspensions of Aspergillus brasiliensis ATCC 16404

The culture from the second passage tube is streaked on Potato Dextrose Agar and incubated at room temperature for approx. one week to obtain strong sporulation (blackening of the colonies). A spore suspension is then prepared in Sterile Saline or Sodium Chloride Peptone buffer with 0.1% Tween 80, which can be stored at 4 -12°C for approx. 6 months. For growth promotion tests the spore suspension is diluted in Sterile Normal Saline or Sodium Chloride Peptone buffer to obtain 10-100 cfu in a defined volume.

Alternatively ready-to-use pellets containing a defined number of Aspergillus spores can be used to determine growth promoting or inhibitory properties of the culture media.

For most spore forming organisms like Bacillus subtilis ATCC 6633, Aspergillus brasiliensis ATCC16404, Clostridium Sporogenes ATCC 11437, etc. Spore suspensions can be prepared which can be stored up to six months.

Schematic Representation of Sub-culturing

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