Gamma irradiated sterile powder recommended for the evaluation of sterility in manufacturing process for easy detection of contamination by Media Fill Test.
HiFill™ Test Medium, Sterile powder is a gamma (y) irradiated sterile powder recommended for the evaluation of sterility in manufacturing process for easy detection of contamination by Media Fill Test.
Composition**
Ingredients
Gms / Litre
HiVeg® hydrolysate
17.000
Soya peptone
3.000
Sodium chloride
5.000
Dipotassium hydrogen phosphate
2.500
Dextrose (Glucose)
2.500
MFT indicator
0.100
Final pH (at 25°C)
7.3± 0.2
**Formula adjusted, standardized to suit performance parameters
Directions
Sterile powder can be used directly for the evaluation of sterility in manufacturing process. For sterile liquid medium aseptically add 30.10 grams in 1000 ml sterile distilled /purified water. DO NOT AUTOCLAVE. Dispense aseptically in sterile tubes or flasks as desired.
Note: If any fibres are observed in the solution it is recommended to filter the solution through 0.22 micron filter to eliminate any possibility of presence of fibres.
Principle And Interpretation
Soyabean Casein Digest Medium is recommended by various pharmacopoeia as sterility testing medium (1-5). HiFill™ Test HiVeg® Medium, Sterile Powder is prepared by completely replacing animal based peptone with vegetable peptones to avoid BSE/TSE risks associated with animal peptones.
HiVeg® hydrolysate and Soya peptone in the medium provides nitrogenous and carbonaceous compounds, long chain amino acids, vitamins and other essential nutrients. Sodium chloride maintains the osmotic balance. Phosphate buffers the medium. Dextrose serves as an energy source. In this line the HiFill™ Test Medium with the addition of MFT indicator, helps to verify the microbiological growth in aseptic production process. MFT Indicator is the medium is utilized by all microorganisms and the microbial contamination is indicated by colour change from light yellow to maroon-red. It is an easier method for detection of contamination with no time consumption.
Type of specimen
Pharmaceutical samples
Specimen Collection and Handling:
For pharmaceutical samples follow appropriate techniques for handling samples as per established guidelines (1-5). After use, contaminated materials must be sterilized by autoclaving before discarding.
Warning and Precautions :
Read the label before opening the container. Wear protective gloves/protective clothing/eye protection/ face protection. Follow good microbiological lab practices while handling specimens and culture. Standard precautions as per established guidelines should be followed while handling specimens. Safety guidelines may be referred in individual safety data sheets.
Limitations :
NA
Performance and Evaluation
Performance of the medium is expected when used as per the direction on the label expiry period when stored at within the recommended temperature.
Quality Control
Appearance Cream to yellow homogeneous free flowing sterile powder
Colour and Clarity of prepared medium Yellow coloured clear solution
Reaction Reaction of 3.01% w/v aqueous solution at 25°C. pH: 7.30±0.20
pH 7.10-7.50
Sterility Check No growth is observed after 14 days for Bacteria at 30-35°C and for Fungi at 20-25°C.
Growth Promotion
Cultural characteristics observed after an incubation at 30-35°C for <= 3days for Bacterial and at 20-25°C for <= 5days for Fungal (* under anaerobic condition).
Sterility Testing + Validation
The medium is tested with suitable strains of microorganisms inoculating <=100cfu and incubating at 20-25°C for not more than 3 days in case of bacteria and not more than 5 days in case of fungi.
Store between 10-30°C in a tightly closed container and the prepared medium at 2-8°C. Use before expiry date on the label. On opening, product should be properly stored dry, after tightly capping the bottle in order to prevent lump formation due to the hygroscopic nature of the product. Improper storage of the product may lead to lump formation. Store in dry ventilated area protected from extremes of temperature and sources of ignition Seal the container tightly after use.
Product performance is best if used within stated expiry period.
Disposal
User must ensure safe disposal by autoclaving and/or incineration of used or unusable preparations of this product. Follow established laboratory procedures in disposing of infectious materials and material that comes into contact with sample must be decontaminated and disposed of in accordance with current laboratory techniques (6,7).
HiFill™ Test HiVeg® Medium is formulated to provide a highly nutritious environment that supports the recovery and detection of aerobic microorganisms during media fill and sterility assurance procedures. Each component has a specific role in promoting microbial growth or maintaining optimal test conditions:
HiVeg® Hydrolysate (17.000 g/L):
This is a vegetable-derived peptide and amino acid source that supplies essential nitrogenous compounds, vitamins, and growth factors required for robust microbial metabolism and replication. Unlike traditional animal-based peptones, HiVeg® hydrolysate minimizes risks associated with animal-origin materials while ensuring broad microbial recovery.
Soya Peptone (3.000 g/L):
Provides additional peptides, amino acids, and nutrients that complement the HiVeg® hydrolysate, enhancing the medium’s capacity to support fastidious aerobic bacteria and fungi.
Sodium Chloride (5.000 g/L):
Maintains osmotic balance within the medium, ensuring that cells remain in a physiologically favorable environment during growth.
Dipotassium Hydrogen Phosphate (2.500 g/L):
Acts as a buffering agent that helps to stabilize the pH of the medium during microbial metabolism and growth, which is essential for reproducible test results.
Dextrose (Glucose) (2.500 g/L):
Serves as a readily fermentable carbohydrate source, providing energy required for cellular respiration and proliferation.
MFT Indicator (0.100 g/L):
A chromogenic indicator that enables visual detection of microbial growth during media fill tests. In the presence of viable microorganisms, the medium changes color from light yellow to maroon-red, simplifying result interpretation without the need for subculturing.
Final pH (at 25°C): 7.3 ± 0.2
This pH range is physiologically suitable for the growth of a wide range of aerobic bacteria and fungi.
Together, these components create a balanced and nutrient-rich medium that supports broad microbial recovery, provides clear visual indication of contamination, and is ideal for process simulation and sterility assurance applications.
HiFill™ Test HiVeg® Medium contributes to sterility assurance in pharmaceutical and aseptic manufacturing environments by serving as a sensitive and reliable indicator of microbial contamination during process validation (e.g., media fill tests) and sterility checks. It does not impart “sterility” itself, but its formulation and properties enable accurate detection of viable microorganisms, ensuring the integrity of sterility test outcomes. Specifically:
Comprehensive Nutrient Support:
The medium contains a balanced mix of HiVeg® hydrolysate, soya peptone, glucose, and buffering agents that supply essential carbon, nitrogen, energy sources, and growth factors. This nutritive environment supports the growth of a broad spectrum of aerobic microorganisms if present in the sample or process simulation.
Visual Growth Indication:
The integrated MFT indicator provides a clear visual signal; the medium changes color from light yellow to maroon-red upon microbial growth. This color change enables rapid detection of contamination without the need for time-consuming subculturing or secondary tests.
Validated Performance:
HiFill™ Test HiVeg® Medium is manufactured under stringent quality control and is gamma-irradiated to ensure sterility prior to use. Each batch is evaluated to confirm its performance criteria for media fill and sterility simulation tests.
Sensitive Detection:
Because the medium supports even low levels of viable microorganisms and produces a distinct color change, it helps identify failures in aseptic processes, cleanroom control, or handling techniques that could otherwise go undetected.
HiFill™ Test HiVeg® Medium is optimally used during aseptic process validation and routine sterility assurance activities, particularly in pharmaceutical and biotechnology manufacturing environments. The most appropriate situations include:
During Media Fill (Process Simulation) Tests:
The medium is specially developed for aseptic process simulation (media fill) studies, where it is used in place of the actual pharmaceutical product to verify whether the manufacturing process maintains sterility.
It should be used during the initial validation of an aseptic process, and whenever significant changes occur, such as new equipment installation, major maintenance, facility modifications, or changes in operating procedures or personnel.
Periodic Revalidation of Aseptic Processes:
Regulatory guidelines require routine requalification of aseptic manufacturing lines. The medium is ideally used at scheduled intervals (e.g., semi-annually or annually, depending on regulatory requirements and risk assessment).
After Process Deviations or Contamination Events:
If an environmental monitoring excursion, sterility failure, or procedural deviation occurs, the medium can be used during corrective validation runs to confirm restoration of aseptic control.
Training and Qualification of Personnel:
It is effectively used during operator qualification programs to assess aseptic handling skills and compliance with cleanroom protocols.
HiFill™ Test HiVeg® Medium offers several distinct advantages that make it a reliable choice for aseptic process simulation and sterility assurance:
Vegetable-based (HiVeg® formulation):
Unlike conventional media that contain animal-derived components, HiVeg® medium uses plant-based peptones. This reduces the risk of variability and eliminates concerns related to animal-origin contaminants such as BSE/TSE.
Optimized for Media Fill Studies:
The formulation is specifically designed to simulate pharmaceutical products during aseptic process validation, supporting the recovery of a broad spectrum of aerobic bacteria and fungi as required in compendial guidelines.
Consistent Growth Promotion:
Manufactured under stringent quality controls, the medium demonstrates reliable growth promotion performance for challenge microorganisms, ensuring confidence in sterility test outcomes.
Ready-to-Use Convenience:
Pre-filled and sterilized formats minimize preparation steps, reduce handling errors, and lower the risk of laboratory-introduced contamination—critical in high-throughput pharmaceutical environments.
Regulatory Compliance:
Designed to align with pharmacopeial expectations (USP, EP, JP) for aseptic process simulation, helping manufacturers meet global regulatory requirements.
Operational Efficiency:
By offering dependable clarity, stability, and reproducibility, it reduces false positives and retesting, ultimately saving time and operational costs.
HiFill™ Test Medium, Sterile Powder is specifically designed for use in aseptic process simulation studies, commonly known as Media Fill Tests, in pharmaceutical manufacturing. This gamma (γ) irradiated sterile powder serves as a microbiological growth medium that replaces the actual pharmaceutical product during simulation runs. Its primary purpose is to evaluate the effectiveness of aseptic manufacturing operations by detecting any potential microbial contamination that may occur during filling, handling, or processing.
Its intended uses include:
Aseptic Process Validation:
Used to validate sterile manufacturing processes by simulating real production conditions without risking actual product contamination.
Contamination Detection:
Supports the growth of a broad range of microorganisms, enabling clear and early detection of contamination if aseptic controls fail.
Regulatory Compliance:
Helps manufacturers meet regulatory expectations outlined in global guidelines (e.g., FDA, EU GMP, WHO) for aseptic process simulation and sterility assurance.
Routine Requalification:
Recommended for periodic revalidation of aseptic lines, especially after equipment modifications, facility upgrades, process changes, or personnel shifts.
Risk Mitigation:
Assists in identifying weaknesses in cleanroom practices, sterilization procedures, environmental controls, and operator techniques before commercial production.
Because it is gamma irradiated and supplied as a sterile powder, the medium reduces the risk of pre-use contamination and simplifies preparation, making it a reliable and practical choice for high-stakes sterility validation programs.
HiFill™ Test HiVeg® Medium is designed for aseptic process simulation and sterility testing. Proper preparation and handling ensure reliable results and prevent contamination:
Direct Use of Sterile Powder:
The gamma-irradiated sterile powder can be used directly for evaluating sterility in manufacturing processes, such as Media Fill Tests. No further sterilization is required.
Preparation of Liquid Medium:
Aseptically dissolve 30.10 g of HiFill™ Test HiVeg® Medium in 1000 mL of sterile distilled or purified water.
Do not autoclave, as the medium is already sterile.
Mix gently until fully dissolved.
Dispensing:
Dispense the medium aseptically into sterile tubes, bottles, or flasks according to the requirements of the sterility study or media fill protocol.
Filtration (if needed):
If any fibers or particulate matter are observed in the solution, filter the medium through a 0.22 µm membrane filter to remove impurities before use.
Handling Precautions:
Use sterile techniques at all times to prevent contamination.
Wear appropriate personal protective equipment (PPE) including gloves, lab coat, and safety goggles.
Treat any used or excess medium as potentially infectious and dispose of it according to institutional biosafety guidelines.
HiFill™ Test HiVeg® Medium, Sterile Powder is designed for aseptic process simulation and sterility testing in pharmaceutical manufacturing. It builds on the principles of Soyabean Casein Digest Medium, which is widely recommended by various pharmacopeias for sterility testing.
This medium is formulated by completely replacing animal-based peptones with vegetable-derived peptones (HiVeg® hydrolysate and soya peptone) to eliminate risks associated with BSE/TSE contamination from animal sources.
HiFill™ Test HiVeg® Medium allows for rapid and reliable detection of microbial contamination during aseptic process simulations:
When used in Media Fill Tests, the medium serves as a surrogate for the actual product, supporting the growth of any contaminating microorganisms that may be introduced during the aseptic process.
No color change (remains light yellow): Indicates that no detectable microbial contamination is present, suggesting that the aseptic process and handling were effective.
Color change to maroon red: Indicates microbial growth, signaling the presence of contamination in the process, environment, or handling. This provides a clear and immediate visual cue for further investigation and corrective action.
The MFT indicator ensures that microbial growth is easily observed, eliminating the need for additional subculturing or complex testing, thus making contamination detection faster and more straightforward.
Problem:
Sterility testing laboratories frequently face the risk of contamination arising from non-sterile environments, manual media preparation, and increased handling steps. Such contamination can lead to false positives, test failures, and delays in product release.
Solution:
HiFill™ Test HiVeg® Medium is a pre-filled, ready-to-use, plant-based sterility testing medium manufactured under controlled conditions. By minimizing manual handling and preparation steps, it significantly reduces the risk of external contamination and ensures consistent sterility performance across routine testing workflows.
Result:
Laboratories can achieve reliable sterility test results that support compliance with pharmacopeial standards such as USP, EP, and JP. This leads to improved laboratory efficiency through reduced repeat testing, faster turnaround times, and enhanced confidence in sterility assurance.
Case-Based Scenario 2:
Problem:
Pharmaceutical QC laboratories require consistent, reproducible sterility testing media to meet stringent regulatory expectations. Variability in media quality or preparation can compromise data integrity and delay batch release.
Solution:
HiFill™ Test HiVeg® Medium offers a standardized formulation, consistent fill volumes, and batch-to-batch reproducibility. Its animal-origin-free composition aligns with modern regulatory and ethical expectations, particularly for global pharmaceutical manufacturers.
Result:
QC teams benefit from enhanced data consistency, smoother regulatory audits, and faster decision-making during batch release, while maintaining alignment with global sterility testing standards.
Case-Based Scenario 3:
Problem:
Contract testing laboratories handling high sample volumes face pressure to deliver accurate sterility results within tight timelines. Manual media preparation can limit throughput and increase the risk of human error.
Solution:
The ready-to-use HiFill™ Test HiVeg® Medium streamlines workflows by eliminating media preparation steps. Its compatibility with routine sterility testing procedures makes it suitable for high-throughput environments.
Result:
Improved laboratory productivity, reduced hands-on time, and greater confidence in sterility testing outcomes support faster client turnaround and improved service reliability.
Case-Based Scenario 4:
Problem:
During regulatory inspections, sterility testing processes are closely scrutinized for consistency, traceability, and compliance with pharmacopeial requirements. Variations in in-house media preparation, documentation gaps, or reliance on animal-origin components can raise audit observations and increase compliance risk.
Solution:
HiFill™ Test HiVeg® Medium is a ready-to-use, animal-origin-free sterility testing medium supplied with comprehensive quality documentation and consistent manufacturing controls. Its standardized formulation and pre-filled format support uniform testing practices and simplified documentation during audits.
Result:
Laboratories can demonstrate stronger regulatory compliance, streamline audit responses, and reduce the likelihood of observations related to sterility testing practices. This supports smoother inspections and sustains regulatory confidence.
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