Soybean-Casein Digest Agar (EP) - BioReagent

Cat. No.: S1528403

GRADE & PURITY BioReagent

Storage

Room temperature

Shipped In

Normal

Panoramica

For total bacterial count determination in pharmaceuticals. Preparation method: Weigh 40.0 g of this product in 1 L of distilled or deionized water, heat with stirring and boil until completely dissolved, dispense and autoclave at 121°C for 15 minutes. After sterilization, shake well to prevent agar from settling and solidifying at the bottom of the vessel, then set aside for use.

Specifications

Specifiche e purezza

BioReagent

Condizioni di conservazione di stoccaggio

Room temperature

Spedito in

Normal

Grado

BioReagent

Product Line

Prodotti biologici

Application Protocols

General-use protocols for Soybean-Casein Digest Agar (EP) plates (literature guidance; adapt to your SOP):

• Pour plate preparation:

  1. Prepare and sterilize the medium as described under Reaction Conditions.
  2. Cool to 45–50 °C. For pour plates, pipette sample or dilution into a sterile Petri dish, then add ~15–20 mL molten agar. Swirl gently to mix. Allow to solidify.
  3. Invert plates and incubate: 30–35 °C for bacteria (18–72 h) or 20–25 °C for fungi (up to 5 days), as required.

• Spread plate method:

  1. Pour sterile plates and dry surface (e.g., 10–20 minutes in a biosafety cabinet).
  2. Spread 0.1 mL of appropriate dilution across the surface with a sterile spreader.
  3. Incubate as per method requirements; count colonies (30–300 CFU ideally) to quantify bioburden.

• Environmental monitoring (contact/RODAC plates):

  1. Press contact plate gently onto the test surface with even pressure; replace lid.
  2. Incubate per EM program; record and trend CFU and morphology.

Quality controls (literature): Include sterility checks of uninoculated plates and growth-promotion tests with compendial strains to confirm performance for each batch of prepared media.

Biological Roles

While not a single biomolecule, Soybean-Casein Digest Agar (EP) provides a balanced nutrient environment that supports the biology of many microorganisms (literature):

• Carbon and energy: Peptones and residual carbohydrates provide readily metabolizable substrates for heterotrophic growth.
• Nitrogen and growth factors: Casein and soybean digests supply peptides, amino acids, vitamins, and trace elements that facilitate recovery of a broad range of aerobic and facultative organisms, including stressed cells.
• Osmotic balance: Sodium chloride maintains an ionic strength favorable for many bacteria, preserving cell integrity.
• Solid support: Agar provides a non-nutritive, inert gelling matrix enabling colony formation and isolation from mixed populations.

Use cases in biological workflows (literature):

• Enumeration of bioburden in water systems, raw materials, in-process samples, and finished products where non-selective recovery is required.
• Environmental monitoring (air, surfaces, personnel) in cleanroom settings; supports detection of a wide range of environmental isolates.
• Maintenance and stock culture preparation for routine laboratory strains.

Note: Some fastidious organisms may require enriched media (e.g., addition of blood, serum, or specific growth factors). Selection of culture medium should be aligned with the organism’s nutritional requirements and the compendial method in use.

Buffer Applications

This product is not a dedicated buffering reagent.

• pH context (literature): Prepared soybean-casein digest agar is typically adjusted to approximately neutral pH (about 7.3 ± 0.2 at 25 °C), affording moderate buffering capacity from the peptone matrix but not functioning as a defined buffer system.
• Practical note: If precise buffering is needed for selective studies (e.g., enzyme assays on plates), consider supplementing with a defined buffer (e.g., phosphate buffer) or using a specialized medium formulated with explicit buffering salts.

For buffer preparation needs, use dedicated buffer reagents; this medium serves primarily as a nutrient and solid support.

Green Alternatives

Environmental considerations for culture media focus on source materials, energy for sterilization, and waste management rather than solvent toxicity.

• Source materials: TSA combines animal-derived casein peptone with plant-derived soybean peptone. Laboratories seeking reduced animal-origin inputs may consider plant-only peptone agars (literature), acknowledging potential differences in recovery of fastidious organisms.
• Energy use: Autoclaving at 121 °C is energy-intensive. Consolidating sterilization cycles, using validated shorter cycles where appropriate, and preparing only the volume needed can reduce energy consumption (general best practice).
• Waste minimization: Prepare minimal amounts, and use reusable glassware when feasible. Autoclave plates after use and segregate biohazardous waste per regulations.

Example comparison (literature, general):

• Soybean-Casein Digest Agar (this product): Broad-spectrum performance; contains animal-derived casein peptides; standard autoclave sterilization.
• Vegetable-peptone Agar: Animal-origin–free; may show slightly altered growth profiles for some organisms; same sterilization requirements.
• Ready-to-use irradiated plates: Reduce in-house sterilization energy but increase packaging waste; may have shorter shelf life once opened.

Trade-offs should be evaluated within your QA and environmental management system.

Pharmaceutical Uses

No therapeutic use. For research and quality-control applications only.

Typical roles in pharmaceutical/biotech QC (literature):

• Sterility testing and microbial enumeration: Non-selective agar for membrane filtration or direct plating steps per EP/USP/JP harmonized chapters, with growth promotion verification.
• Environmental monitoring: Settle plates, contact plates, and swab recovery for cleanroom monitoring programs; often incubated at 30–35 °C for bacterial bioburden and at 20–25 °C for fungi (institutional SOP-dependent).
• In-process control: Recovery of aerobic heterotrophs from water systems and non-sterile products in microbial limits tests.

Regulatory considerations (general):

• Media used in compendial methods require documented growth-promotion testing with reference strains, lot traceability, and defined storage/expiry. Follow your site’s quality system and applicable pharmacopeial chapters.

This information is provided for formulation/manufacturing QC context only and does not imply any clinical application.

Physical Properties

• Physical state: Dehydrated, free-flowing powder that forms a clear-to-slightly opalescent, firm gel after sterilization and cooling (literature).
• Color/appearance: Typically light tan to beige as powder; plates are pale amber (literature). Not specified for this item; refer to CoA/Spec Sheet.
• Solubility: Designed to dissolve/disperse in water with heating; insoluble in organic solvents (literature).
• pH of prepared medium: Typically ~7.3 ± 0.2 at 25 °C (literature, EP/USP harmonized media specification). Not specified for this item; refer to CoA/Spec Sheet.
• Gelation: Agar sets on cooling to ~35–40 °C to yield a firm surface suitable for colony isolation; melts at ~85–90 °C (agar literature values).
• Density/bulk density (powder): Not specified for this item; refer to CoA/Spec Sheet.
• Moisture content and ash: Not specified for this item; refer to CoA/Spec Sheet.
• Refractive index, logP, pKa, UV cutoff: Not applicable/Not defined for this complex mixture.

Notes: Values above are general literature characteristics for soybean-casein digest agar (TSA)-type media and are provided for context only; they are not item-specific specifications.

Quality and Grades

• Item-specific grade: BioReagent (from Product Data). BioReagent-grade materials are suitable for biological and microbiological laboratory workflows and are manufactured with attention to contaminants that could inhibit growth or interfere with biological assays.
• Compendial context: “(EP)” indicates formulation and performance suitability aligned with European Pharmacopoeia methods (e.g., growth promotion tests, sterility testing), subject to growth promotion verification using compendial strains (literature).
• Growth promotion (literature context): For TSA/soybean-casein digest agar, EP/USP growth-promotion testing typically includes organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus brasiliensis, demonstrating expected recovery and morphology under defined conditions. These details are literature guidance, not item-specific specifications.
• Appearance and performance: Not specified for this item; refer to CoA/Spec Sheet for lot-specific confirmation tests (pH, recovery ratios, sterility of dehydrated medium, etc.).
• Stabilizers/preservatives: None typically added to dehydrated media beyond the core formulation (literature). Any additives for this item are Not specified for this item; refer to CoA/Spec Sheet.

Documentation recommendation: For regulated workflows, retain the lot CoA and, where required, perform on-receipt growth-promotion verification per your quality system.

Reaction and Applications

As a complex microbiological medium, Soybean-Casein Digest Agar (EP) is used for cultivating a wide range of microorganisms; it is not used as a reagent in chemical reactions.

Key laboratory applications (literature):

• General-purpose isolation and maintenance of aerobic and facultative anaerobic bacteria from clinical, industrial, food, and environmental sources.
• Microbial limit testing and environmental monitoring in pharmaceutical and biotech facilities (e.g., settle plates, contact plates, surface swabs plated onto TSA).
• Growth promotion testing (GPT) as a performance qualification step for sterility tests and microbial enumeration methods.
• Subculture/recovery of stressed organisms following sanitization or processing, due to its rich nutrient base (peptones and sodium chloride) and non-selective nature.
• Colony morphology assessment and enumeration (CFU counting) using pour-plate or spread-plate techniques.

Practical tips (literature):

• Thoroughly dissolve medium by heating; autoclave at 121 °C for ~15 minutes. Cool to 45–50 °C before pouring to avoid condensation and to preserve heat-labile supplements if added.
• For fungi/yeasts, TSA can be used but specialized media (e.g., Sabouraud) may provide enhanced recovery; supplementing TSA with antifungals can render it more selective when required.
• Perform routine QC (pH check, sterility check, GPT) on each prepared batch per institutional SOPs.

Reaction Conditions

This section provides general preparation and use conditions for the medium, not chemical reaction conditions.

Typical preparation (literature guidance):

• Reconstitution: Suspend ~40 g of dehydrated medium per liter of purified water (common TSA formulation; check your SOP/CoA for exact mass). Mix thoroughly.
• Dissolution: Heat with frequent agitation to bring to a gentle boil until the agar is fully dissolved and the solution is uniform.
• Sterilization: Autoclave at 121 °C for ~15 minutes. Avoid over-sterilization which can darken the medium and reduce performance.
• Cooling and pouring: Cool to 45–50 °C, mix gently to distribute condensate, and pour into sterile plates or tubes. Allow to solidify on a level surface.
• pH: Final pH typically ~7.3 ± 0.2 at 25 °C (literature). Adjust prior to sterilization if your method requires.

Incubation guidance (literature):

• General aerobic bacteria: 30–35 °C for 18–72 h depending on organism and bioburden.
• Environmental isolates/yeasts/molds: 20–25 °C or dual incubation schemes per SOP.

All numeric values above are general literature norms for soybean-casein digest agar and are not item-specific specifications. Always follow your validated method and consult the product CoA/Spec Sheet.

Safety and Handling

• GHS classification, signal word, pictograms: Not specified for this item; refer to SDS.
• General hazards: Non-sterile dehydrated culture media are not intrinsically pathogenic but are intended to support microbial growth once reconstituted and sterilized. Handle sterile-prepared media as a biohazard after inoculation. Avoid inhalation of dust; dust may cause mechanical irritation (literature, general lab practice).
• PPE: Lab coat, safety glasses, and suitable gloves. Use dust control measures when weighing (fume hood or local exhaust if available).
• Incompatibilities: Avoid strong oxidizers and moisture during storage; keep container tightly closed to prevent caking and reduced performance (general guidance).
• First aid (general): If inhaled, move to fresh air; if on skin/eyes, rinse with water; if ingested, rinse mouth. Seek medical attention if symptoms persist. Defer to SDS for authoritative instructions.
• Thermal processing: Boiling to dissolve agar and autoclaving at 121 °C are standard; use heat-resistant gloves and follow autoclave safety protocols.
• Microbiological safety: After use, all plates/broths must be autoclaved or otherwise disinfected prior to disposal according to institutional biosafety procedures.

Always consult the product SDS and institutional risk assessments before use.

Solvent Selection

This product is a dehydrated culture medium intended to be prepared in purified water.

• Primary solvent: Water (purified/distilled/deionized). Organic solvents are not appropriate.
• Water quality: Use water that meets your laboratory’s microbiological media specifications (e.g., ASTM Type I/II or EP Purified Water), with low microbial and endotoxin burden to ensure consistent performance (general guidance, literature).
• Dissolution behavior: Requires heating to near-boil to fully dissolve agar; complete dissolution is evident when the solution is clear to slightly opalescent (literature).
• Comparison with alternatives:
  • Soybean-Casein Digest Broth (TSB): Broth analog without agar for liquid culture and sterility tests where a gel is not required (literature).
  • Other agar media (e.g., Nutrient Agar, Sabouraud Dextrose Agar): Selected based on nutritional profile and target organisms; TSA offers broad-spectrum, non-selective growth (literature).

When to choose this medium: Use when a non-selective, general-purpose surface for aerobic heterotrophs is desired, including environmental monitoring and bioburden assessments (literature).

Storage and Reconstitution

• Storage conditions (dehydrated medium): Room temperature (from Product Data). Protect from moisture and light. Keep container tightly closed. Shipped at ambient conditions (from Product Data: Normal).
• Shelf life: Not specified for this item; refer to CoA/Spec Sheet.
• Reconstitution (literature guidance):
  • Typical dose: Approximately 40 g/L in purified water for standard TSA; verify exact mass per your SOP/CoA.
  • Dissolve by heating to near boil with agitation; autoclave at 121 °C for ~15 min. Cool to 45–50 °C before pouring plates or dispensing into tubes.
  • If adding heat-labile supplements (e.g., neutralizers for disinfectant testing), aseptically add to cooled (45–50 °C) sterile base.
• Storage of prepared media (literature): Store sealed plates at 2–8 °C, protected from dehydration and contamination. Allow plates to equilibrate to room temperature and remove surface condensation before inoculation. Use within the validated in-house expiry.
• Freeze–thaw: Do not freeze dehydrated medium or prepared plates; freezing disrupts agar matrix and degrades performance.

Always consult the product’s CoA/Spec Sheet and your institutional SOPs for lot-specific directions and performance criteria.

Structure and Identity

Soybean-Casein Digest Agar (EP) is a complex, multi-component microbiological culture medium (often synonymous with Tryptic Soy Agar, TSA) formulated from peptones and agar; it is not a single defined chemical entity.

• Item identity: Complex nutrient agar medium per European Pharmacopoeia (EP) principles; also known as TSA (literature).
• Composition nature: Mixture of pancreatic digest of casein (animal-derived peptides), papaic/enzymatic digest of soybean meal (plant-derived peptides), sodium chloride, and agar as a gelling agent (literature).
• Molecular formula: Not applicable to mixtures. Not specified for this item; refer to CoA/Spec Sheet.
• Molecular weight: Not applicable to mixtures. Not specified for this item; refer to CoA/Spec Sheet.
• SMILES / InChIKey: Not applicable to mixtures. Not specified for this item; refer to CoA/Spec Sheet.
• Structural features (2D description): Not a discrete molecule; consists of heterogeneous peptides, amino acids, carbohydrates, salts, and polysaccharide (agar) that gels upon cooling from melt (literature).
• Regulatory/compendial context: “(EP)” indicates suitability for procedures harmonized or referenced by the European Pharmacopoeia, e.g., growth promotion/sterility test media (literature).

Synthetic Utility

Not applicable. Soybean-Casein Digest Agar (EP) is a biological culture medium rather than a synthetic chemistry reagent. It does not serve as a functional group donor/acceptor or participate in named organic reactions. For applications relevant to this product, see Reaction & Applications and Application Protocols sections.

Target Specificity

Not applicable. This product is not an antibody or affinity reagent and has no antigen/epitope specificity. It is a non-selective culture medium intended to support a broad range of microorganisms (literature).