Common Types of Media for USP Microbiology

LAB 797 offers various types of biological media for your sampling needs. All media sold by LAB 797 is sterile, gamma-irradiated, and includes a certificate of quality and growth promotion (documents available by request). Media is used to support the growth of bacteria, molds, and yeast. We offer four types of media that are in stock and ready to ship to your facility. 

• TSA (Tryptic Soy Agar) Air Plates

  • Used for growth of bacteria, but can also grow molds and yeasts

  • 85mm plates ideal for use with impaction air samplers

• TSA  (Tryptic Soy Agar) Contact Plates

  • Used for growth of bacteria, but can also grow molds and yeasts

  • Contains Lecithin and Polysorbate-80 for neutralization of chemicals used for cleaning

  • Ideal for use for fingertip sampling and surface sampling

  • Can also be used in SAS air samplers

• SDA (Sabouraud Dextrose Agar) Air Plates

  • Used for growth of molds and yeasts

  • 85mm plates ideal for use with impaction air samplers

• SDA (Sabouraud Dextrose Agar) Contact Plates

  • Used for growth of molds and yeasts

  • Contains Lecithin and Polysorbate-80 for neutralization of chemicals used for cleaning

  • Ideal for use for fingertip sampling and surface sampling

  • Can also be used in SAS air samplers

LAB 797 also offers media-fill solutions by request. This can include TSB (Tryptic Soy Broth), as well as other items such as bags, ports, needles, and vials.

Incubation 101

What Types of Incubation Do We Offer?

With various options for incubation, making sure your pharmacy or business is doing the right thing can be confusing. LAB 797 is here to help and make your sampling as easy and efficient as possible. Incubation refers to a process used to promote the growth and development of an organism. In this case, incubation is needed for any bacteria, mold, or yeasts to grow on the media. Special laboratory devices called incubators control temperature to promote growth of these organisms. There are four main types of incubation as described below.

Incubation

• Standard Incubation @ 30-35 C: This temperature promotes the growth of common bacteria found in the environment and on people such as Bacillus sp., Micrococcus sp., and Staphylococcus sp. This incubation is done over a period of three to four days at the temperature of 30-35 C. Common media types used for this type of incubation include Tryptic Soy Agar (TSA) and Blood Agar.

• Standard Incubation @ 20-25 C: This temperature promotes the growth of common molds and yeasts found in the environment and on people, such as Cladosporium sp., Aspergillus sp., Penicillium sp., and Candida sp. This incubation is done over a period of six to seven days at the temperature of 20-25 C. Common media types used for this type of incubation include Sabouraud Dextrose Agar (SDA) and Malt Extract Agar (MEA).  

• Dual Incubation @ 30-35 C, then @ 20-25 C: By incubating media at both temperatures, we allow for growth of bacteria, molds, and yeasts. This is usually done if only one media type (usually Tryptic Soy Agar) is desired. Media is incubated first at 30-35 C for a period of three to four days, then transferred to 20-25 C for a period of six to seven days.

• Dual Incubation @ 20-25 C, then @ 30-35 C: This incubation is done only for Media Fill samples. Samples are incubated at 20-25 C for a period of seven days, then transferred to 30-35 C for a period of seven days. 

Once incubation is completed, colonies of bacteria, yeasts, and molds are counted and then identified. These results are sent back to your pharmacy or business once incubation is completed and samples are analyzed. 

USP 797 Revisions... How Will Your Pharmacy Be Affected?

With the new revision of USP<797> on its way, many pharmacists are concerned about how these new regulations will affect their business. But what exactly has changed within the new revision? Among the most significant changes is the removal of low, medium, and high risk CSP categories. These designations have been replaced with category 1 and category 2 CSPs. The categories are now dictated by the BUD and the environment in which the product was compounded. The chart below shows the major differences between category 1 and 2 CSPs:

Another major change within the new USP<797> revision is the frequency at which environmental and personnel viable monitoring must be done. Current USP<797> protocols state that media fill testing and fingertip testing of all compounding personnel must be done either annually or semi-annually – depending on the risk level. New USP revisions call for these test to be done by all personnel quarterly, regardless of the category designation of the product. The frequency at which viable air sampling must be done has also increased. Although air sampling for cleanroom certification remains semi-annually, air sampling to evaluate air cleanliness must be done monthly by the pharmacist. This inherently creates issues for pharmacists that have not previously had to do their own air sampling. In addition to monthly viable air sampling, monthly surface samples must also be taken within each area of the cleanroom.

Many other smaller changes have been made within the USP<797> revision. For example, master formulation records must be kept for all manipulations made of any compounds, including non-sterile manipulations and dilution processes. A new concept called “in-use time” has also been introduced in the revision which regulates the amount of time that a sterile product can be used once opened or pierced.

Although the new regulations will require more testing and documentation to comply with regulations, the FDA is hoping that implementation of the revised USP<797> will reduce illness and death associated with sterile compounding. With the implementation of these new regulations in the now foreseeable future, pharmacists must begin preparing to comply with the new USP standards. Since environmental and personnel monitoring must be done monthly by the pharmacist, a suitable supplier of media and laboratory services is necessary. LAB 797 offers quality media and laboratory services – including speciation of all viable organisms recovered. Revision of internal SOPs is also crucial to comply with these changes. Although a specific release date has not been set by USP and the FDA, pharmacists are encouraged to begin considering these new regulations now – inherently saving time and stress when the official revision is published.

For more information on USP 797 and updated revisions release dates, check out USP's website