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HiFill™ Test HiVeg® Medium
SKU:
MV2018G
Availability:
Out of stock
Currently out of stock — you can still place your order, and the quantity will be fulfilled on backorder.
Only %1 left
As low as
$74.00
Gamma irradiated sterile powder recommended for the evaluation of sterility in manufacturing process for easy detection of contamination by Media Fill Test.
Intended use
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.
| Organism (ATCC) | Inoculum (CFU) | Growth |
|---|---|---|
| Growth promoting | ||
| Staphylococcus aureus subsp. aureus ATCC 6538 (00032*) | 50-100 | luxuriant w/red to maroon colour |
| Staphylococcus aureus subsp. aureus ATCC 25923 (00034*) | 50-100 | luxuriant w/red to maroon colour |
| Escherichia coli ATCC 8739 (00012*) | 50-100 | luxuriant w/red to maroon colour |
| Escherichia coli ATCC 25922 (00013*) | 50-100 | luxuriant w/red to maroon colour |
| Pseudomonas aeruginosa ATCC 9027 (00026*) | 50-100 | luxuriant w/red to maroon colour |
| Pseudomonas aeruginosa ATCC 27853 (00025*) | 50-100 | luxuriant w/red to maroon colour |
| Bacillus subtilis subsp. spizizenii ATCC 6633 (00003*) | 50-100 | luxuriant w/red to maroon colour |
| #Kocuria rhizophila ATCC 9341 | 50-100 | luxuriant w/red to maroon colour |
| Salmonella Typhimurium ATCC 14028 (00031*) | 50-100 | luxuriant w/red to maroon colour |
| Salmonella Abony NCTC 6017 (00039*) | 50-100 | luxuriantw/red to maroon colour |
| Streptococcus pneumoniae ATCC 6305 | 50-100 | luxuriant w/red to maroon colour |
| Sterility Testing- Growth promotion+Validation | ||
| Candida albicans ATCC 10231 (00054*) | 50-100 | luxuriant w/red to maroon colour |
| Candida albicans ATCC 2091 (00055*) | 50-100 | luxuriant w/red to maroon colour |
| Clostridium perfringens ATCC 12924 | 50-100 | luxuriant w/red to maroon colour |
Key: *Corresponding WDCM numbers.
Storage and Shelf Life
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).
| Product Name | HiFill™ Test HiVeg® Medium |
|---|---|
| SKU | MV2018G |
| Product Type | HiVeg™ |
| Physical Form | Sterile Powder |
| Origin | Animal Free (Veg) |
| Packaging type | HDPE |
| References | To be added |
Case 1
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 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 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 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 workflows 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 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 helps sustain regulatory confidence.
Write Your Own Review
What is the composition of HiFill™ Test HiVeg®Medium?
HiFill™ Test HiVeg®Medium contains HiVeg hydrolysate at 17.0 g/L, providing a vegetable-derived source of peptides, amino acids, vitamins, and growth factors while avoiding animal-origin materials. Soya peptone at 3.0 g/L supplies additional nutrients to support the growth of fastidious aerobes and fungi. Sodium chloride at 5.0 g/L maintains osmotic balance, while dipotassium hydrogen phosphate at 2.5 g/L provides buffering capacity to maintain the required pH. Dextrose at 2.5 g/L serves as a fermentable energy source, and MFT indicator at 0.1 g/L indicates microbial growth through a colour change from light yellow to maroon-red.
How does the HiFill™ Test HiVeg® medium ensure sterility in tests?
HiFill™ Test HiVeg® Medium supports sterility assurance in pharmaceutical and aseptic manufacturing environments by enabling detection of microbial contamination during process validation, including media fill tests, and sterility checks. Its balanced formulation provides HiVeg® hydrolysate, soya peptone, glucose, buffering agents, essential nutrients, and growth factors to support a broad range of aerobic microorganisms. The integrated MFT indicator provides visual detection, changing from light yellow to maroon-red upon microbial growth. Manufactured under stringent quality controls and gamma-irradiated for sterility, each batch is evaluated for performance thus supporting detection of aseptic process failures.
What is the optimal time for using HiFill™ Test HiVeg® medium?
The optimal time for using HiFill™ Test HiVeg® Medium is during aseptic process validation and routine sterility assurance activities, particularly for media fill simulations, investigation of suspected contamination, and periodic revalidation. The prepared medium should be validated for suitability and performance before use. Its use should follow the applicable validated procedure and specified incubation conditions to ensure reliable detection of viable microorganisms.
Where can I access the product’s Safety Data Sheet (SDS)?
All technical documentation, including TDS, SDS, and COA, is available on our localized US portal. - Visit [www.himedialabs.com/us](https://www.himedialabs.com/us). - Search for your specific product code (e.g., MH011G for the standard USP formulation). - High-volume users can also request bulk-batch COAs directly from our Pennsylvania-based support team. - For Technical & Product Support: Email: infous@himedialabs.com
Why choose HiFill™ Test HiVeg® Medium over other sterility testing media?
HiFill™ Test HiVeg® Medium may be preferred over other sterility testing media because its animal-free formulation , helping address concerns related to animal-origin materials. It supports the recovery of a broad range of aerobic bacteria and fungi and provides consistent growth performance. The integrated MFT indicator enables visual detection of microbial growth through a distinct colour change from light yellow to light pink and finally maroon-red. This provides a convenient indication of microbial contamination, making the medium suitable for aseptic process simulation, sterility assurance, and related microbiological applications.
What is the intended use of HiFill™ Test Medium, Sterile Powder?
HiFill™ Test Medium, Sterile Powder is intended for aseptic process simulation (media fill) studies in pharmaceutical manufacturing. It is used in place of the actual product during simulated filling and processing operations to evaluate the effectiveness of aseptic practices. After incubation, microbial growth can indicate potential contamination introduced during filling, handling, or processing, helping assess and maintain the effectiveness of the overall aseptic process.
What are the proper preparation and handling instructions for HiFill™ Test HiVeg® Medium?
HiFill™ Test HiVeg® Medium is designed for aseptic process simulation and sterility testing. As the powder is gamma-irradiated and sterile, no further sterilization is required. For liquid preparation, aseptically dissolve 30.10 g in 1000 mL of sterile distilled or purified water and mix gently until completely dissolved. If fibres or particles are observed, filter the medium through a 0.22 µm membrane before use. Aseptically dispense the prepared medium into suitable sterile containers. Maintain aseptic technique, use appropriate PPE, and dispose of used medium according to applicable biosafety procedures.
Principle of HiFill™ Test HiVeg®
- 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.
Interpretation of HiFill™ Test HiVeg®
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.
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