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Defibrinated Blood Soil, Compliant with ASTM F3208-20

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Product Description

Defibrinated Blood Soil (BZ538) – ASTM F3208-20

Overview: Biochemazone’s Defibrinated Blood Soil (BZ538) is a specially formulated artificial test soil designed for simulated-use soiling of medical devices to support cleaning validation and verification studies. This formulation is based on defibrinated blood components, providing a highly realistic representation of clinical contamination without clot formation, ensuring uniform application and reproducibility. The reconstituted BZ538 contains a complex mixture of proteins, hemoglobin, lipids, and organic components that closely mimic contaminants typically found on medical devices after clinical procedures. Biochemazone’s Defibrinated Blood Soil (BZ538) is specifically developed to align with ASTM F3208-20 requirements, enabling accurate and reliable validation of cleaning processes for reusable medical devices. This product is engineered to simulate the physicochemical behavior of real blood soils while offering improved consistency due to the absence of fibrin, making it ideal for controlled laboratory testing environments. Key Features: Defibrinated Blood-Based Composition: Formulated using defibrinated blood components including hemoglobin, serum proteins, lipids, and electrolytes to simulate clinical contamination without clotting variability. Compliance with ASTM F3208-20: Meets the requirements of ASTM F3208-20 for standardized cleaning validation protocols. Non-Clotting Behavior: Absence of fibrin ensures uniform spreading, consistent adhesion, and reproducible test conditions. Physical Characteristics: Supplied as a deep red liquid or reconstitutable format, closely resembling real blood contamination in appearance and handling. Safe and Stable: Non-hazardous, environmentally considerate, and optimized for stability during storage and testing. Realistic Simulation: Accurately mimics clinical blood soils encountered on reusable medical devices. Applications:

Simulated-use soiling of medical devices for cleaning validation and verification studies
Validation of cleaning processes for surgical instruments, endoscopes, and reusable devices
Evaluation of detergents, enzymatic cleaners, and automated washer-disinfectors
Research and development of advanced cleaning and decontamination technologies

Product Specifications: Product Code: BZ538 Form:

Deep red liquid (ready-to-use) or reconstitutable format

Composition: Defibrinated blood components including hemoglobin, serum proteins, lipids, and electrolyte solution Shelf Life: 12 months under recommended storage conditions Packaging: Available in 50 mL, 100 mL, 200 mL, and 500 mL pack sizes Storage and Handling: Store at 2–8°C in a tightly sealed container. Protect from direct sunlight and extreme temperatures. Use appropriate personal protective equipment (PPE) when handling the product. Ordering Information: To place an order or inquire about bulk purchases, please contact Biochemazone Customer Support or email us at info@biochemazone.com. Storage and Shelf Life Dry Vials: Store at room temperature Reconstituted Vials: Store at 2°C–8°C and use within two weeks General Conditions: Protect from light and heat to maintain efficacy Shelf Life: 12 months for unopened vials Biochemazone® Defibrinated Blood Soil ASTM F3208-20 is a high-performance, ready-to-use test soil engineered to meet the rigorous requirements of ASTM F3208-20. This standardized formulation is essential for accurate validation of cleaning protocols for reusable medical devices, replicating real-world contaminants typically encountered in clinical settings. The Defibrinated Blood Soil ASTM F3208-20 is a premium standardized formulation designed for validating cleaning methods for reusable medical devices. Its precise composition ensures accuracy and reproducibility, making it indispensable for soil testing procedures and cleaning validation protocols. This test soil is widely used across medical and surgical instrumentation applications, providing a realistic and controlled simulation of blood-based contaminants without clotting variability. It is particularly valuable for researchers, engineers, and professionals involved in cleaning efficacy studies and reprocessing validation. Key Features ASTM F3208-20 Compliance: Formulated to meet standardized requirements for reproducible cleaning validation Real-World Contaminant Simulation: Replicates blood-based soils including proteins, hemoglobin, lipids, and organic residues Optimized Physical Properties: Designed for consistent viscosity, adhesion, and spreadability without clot formation Ready-to-Use: Pre-prepared formulation for immediate use and consistent results Customizable Options: Defibrinated Blood Soil (DBLSO) from Biochemazone is a high-fidelity test soil developed to replicate complex blood-based contamination encountered in clinical and laboratory environments. This advanced formulation features defibrinated blood as a primary component, delivering authentic hemoglobin content representative of real biological fluids. Fresh egg yolk is incorporated to provide a rich mixture of proteins, lipids, and carbohydrates, closely simulating the nutritional and structural complexity of organic residues. The addition of bovine calf serum further enhances protein content, mimicking serum-based contaminants commonly found on medical instruments. To complete the matrix, dehydrated hog mucin contributes both a carbon source and increased viscosity, improving adherence and resistance characteristics. Together, these components create a robust and reproducible challenge soil, making DBLSO ideal for evaluating the effectiveness of cleaning agents, disinfectants, and sterilization processes under realistic worst-case conditions. Bulk quantities and custom formulations available upon request Applications Cleaning Validation: Ensures effectiveness of cleaning methods for reusable medical devices Disinfection & Sterilization Testing: Supports evaluation of decontamination procedures Residual Risk Assessment: Assists in identifying remaining contaminants post-cleaning Research & Development: Supports innovation in cleaning technologies Training: Ideal for demonstrating contamination and cleaning validation procedures Specifications Composition: Defibrinated blood-derived formulation including proteins, hemoglobin, lipids, and electrolytes Physical Properties: Optimized viscosity and adhesion to simulate realistic clinical contamination Packaging Options: Available in 50 mL, 100 mL, 200 mL, 500 mL, and bulk quantities Shelf Life: Stable for 12 months under recommended storage conditions (2°C–30°C) Why Choose Biochemazone® Defibrinated Blood Soil ASTM F3208-20? Reusable medical devices are frequently exposed to blood-based contaminants that can interfere with sterilization if not properly removed. Biochemazone® Defibrinated Blood Soil ASTM F3208-20 offers:

Unmatched Consistency: Eliminates clotting variability for reproducible testing
Regulatory Compliance: Supports FDA, AAMI, ISO, and Health Canada guidelines
Realistic Testing Conditions: Simulates blood contamination without fibrin interference
Global Standards Alignment: Complies with ASTM F3208-20 and ISO/TS 15883-5

By choosing Biochemazone, you are selecting a reliable partner dedicated to providing consistent and high-quality solutions for cleaning validation. Order Defibrinated Blood Soil (BZ538) – ASTM F3208-20 Today Streamline your cleaning validation processes with Biochemazone® Defibrinated Blood Soil ASTM F3208-20, the trusted solution for accurate and reproducible testing. 📧 Email: info@biochemazone.com 🌐 Shipping: Available worldwide 📦 Packaging Options: From 50 mL to bulk quantities Place your order today to ensure reliable cleaning validation results that meet global regulatory standards.

Defibrinated Blood Soil (BZ538) – ASTM F3208-20

Overview:

Biochemazone’s Defibrinated Blood Soil (BZ538) is a specially formulated artificial test soil designed for simulated-use soiling of medical devices to support cleaning validation and verification studies. This formulation is based on defibrinated blood components, providing a highly realistic representation of clinical contamination without clot formation, ensuring uniform application and reproducibility.

The reconstituted BZ538 contains a complex mixture of proteins, hemoglobin, lipids, and organic components that closely mimic contaminants typically found on medical devices after clinical procedures. Biochemazone’s Defibrinated Blood Soil (BZ538) is specifically developed to align with ASTM F3208-20 requirements, enabling accurate and reliable validation of cleaning processes for reusable medical devices.

This product is engineered to simulate the physicochemical behavior of real blood soils while offering improved consistency due to the absence of fibrin, making it ideal for controlled laboratory testing environments.

Key Features:

Defibrinated Blood-Based Composition:
Formulated using defibrinated blood components including hemoglobin, serum proteins, lipids, and electrolytes to simulate clinical contamination without clotting variability.

Compliance with ASTM F3208-20:
Meets the requirements of ASTM F3208-20 for standardized cleaning validation protocols.

Non-Clotting Behavior:
Absence of fibrin ensures uniform spreading, consistent adhesion, and reproducible test conditions.

Physical Characteristics:
Supplied as a deep red liquid or reconstitutable format, closely resembling real blood contamination in appearance and handling.

Safe and Stable:
Non-hazardous, environmentally considerate, and optimized for stability during storage and testing.

Realistic Simulation:
Accurately mimics clinical blood soils encountered on reusable medical devices.

Applications:

Simulated-use soiling of medical devices for cleaning validation and verification studies
Validation of cleaning processes for surgical instruments, endoscopes, and reusable devices
Evaluation of detergents, enzymatic cleaners, and automated washer-disinfectors
Research and development of advanced cleaning and decontamination technologies

Product Specifications:

Product Code: BZ538

Form:

Deep red liquid (ready-to-use) or reconstitutable format

Composition:
Defibrinated blood components including hemoglobin, serum proteins, lipids, and electrolyte solution

Shelf Life: 12 months under recommended storage conditions

Packaging: Available in 50 mL, 100 mL, 200 mL, and 500 mL pack sizes

Storage and Handling:

Store at 2–8°C in a tightly sealed container. Protect from direct sunlight and extreme temperatures. Use appropriate personal protective equipment (PPE) when handling the product.

Ordering Information:

To place an order or inquire about bulk purchases, please contact Biochemazone Customer Support or email us at info@biochemazone.com.

Storage and Shelf Life

Dry Vials: Store at room temperature
Reconstituted Vials: Store at 2°C–8°C and use within two weeks
General Conditions: Protect from light and heat to maintain efficacy
Shelf Life: 12 months for unopened vials

Biochemazone® Defibrinated Blood Soil ASTM F3208-20 is a high-performance, ready-to-use test soil engineered to meet the rigorous requirements of ASTM F3208-20. This standardized formulation is essential for accurate validation of cleaning protocols for reusable medical devices, replicating real-world contaminants typically encountered in clinical settings.

The Defibrinated Blood Soil ASTM F3208-20 is a premium standardized formulation designed for validating cleaning methods for reusable medical devices. Its precise composition ensures accuracy and reproducibility, making it indispensable for soil testing procedures and cleaning validation protocols.

This test soil is widely used across medical and surgical instrumentation applications, providing a realistic and controlled simulation of blood-based contaminants without clotting variability. It is particularly valuable for researchers, engineers, and professionals involved in cleaning efficacy studies and reprocessing validation.

Key Features

ASTM F3208-20 Compliance:
Formulated to meet standardized requirements for reproducible cleaning validation

Real-World Contaminant Simulation:
Replicates blood-based soils including proteins, hemoglobin, lipids, and organic residues

Optimized Physical Properties:
Designed for consistent viscosity, adhesion, and spreadability without clot formation

Ready-to-Use:
Pre-prepared formulation for immediate use and consistent results

Customizable Options:

Defibrinated Blood Soil (DBLSO) from Biochemazone is a high-fidelity test soil developed to replicate complex blood-based contamination encountered in clinical and laboratory environments. This advanced formulation features defibrinated blood as a primary component, delivering authentic hemoglobin content representative of real biological fluids. Fresh egg yolk is incorporated to provide a rich mixture of proteins, lipids, and carbohydrates, closely simulating the nutritional and structural complexity of organic residues. The addition of bovine calf serum further enhances protein content, mimicking serum-based contaminants commonly found on medical instruments. To complete the matrix, dehydrated hog mucin contributes both a carbon source and increased viscosity, improving adherence and resistance characteristics. Together, these components create a robust and reproducible challenge soil, making DBLSO ideal for evaluating the effectiveness of cleaning agents, disinfectants, and sterilization processes under realistic worst-case conditions.

Bulk quantities and custom formulations available upon request

Applications

Cleaning Validation:
Ensures effectiveness of cleaning methods for reusable medical devices

Disinfection & Sterilization Testing:
Supports evaluation of decontamination procedures

Residual Risk Assessment:
Assists in identifying remaining contaminants post-cleaning

Research & Development:
Supports innovation in cleaning technologies

Training:
Ideal for demonstrating contamination and cleaning validation procedures

Specifications

Composition:
Defibrinated blood-derived formulation including proteins, hemoglobin, lipids, and electrolytes

Physical Properties:
Optimized viscosity and adhesion to simulate realistic clinical contamination

Packaging Options:
Available in 50 mL, 100 mL, 200 mL, 500 mL, and bulk quantities

Shelf Life:
Stable for 12 months under recommended storage conditions (2°C–30°C)

Why Choose Biochemazone® Defibrinated Blood Soil ASTM F3208-20?

Reusable medical devices are frequently exposed to blood-based contaminants that can interfere with sterilization if not properly removed. Biochemazone® Defibrinated Blood Soil ASTM F3208-20 offers:

Unmatched Consistency: Eliminates clotting variability for reproducible testing
Regulatory Compliance: Supports FDA, AAMI, ISO, and Health Canada guidelines
Realistic Testing Conditions: Simulates blood contamination without fibrin interference
Global Standards Alignment: Complies with ASTM F3208-20 and ISO/TS 15883-5

By choosing Biochemazone, you are selecting a reliable partner dedicated to providing consistent and high-quality solutions for cleaning validation.

Order Defibrinated Blood Soil (BZ538) – ASTM F3208-20 Today

Streamline your cleaning validation processes with Biochemazone® Defibrinated Blood Soil ASTM F3208-20, the trusted solution for accurate and reproducible testing.

📧 Email: info@biochemazone.com
🌐 Shipping: Available worldwide
📦 Packaging Options: From 50 mL to bulk quantities

Place your order today to ensure reliable cleaning validation results that meet global regulatory standards.

Description
Additional information

Description

Defibrinated Blood Soil (BZ538) – ASTM F3208-20 – High-Quality Cleaning Validation Solution by Biochemazone®

Biochemazone’s Defibrinated Blood Soil (BZ538) is a specially formulated artificial test soil designed for simulated-use soiling of medical devices to conduct cleaning validation and verification studies. This product is an essential tool for ensuring thorough and effective cleaning processes for reusable medical devices. The formulation is based on defibrinated blood components, eliminating fibrin to prevent clotting and ensure uniform application and reproducibility.

The BZ538 formulation contains a blend of key biological markers, including hemoglobin, serum proteins, lipids, and electrolytes, closely mimicking contaminants typically found on medical devices after exposure to blood during clinical procedures. Biochemazone’s Defibrinated Blood Soil (BZ538) is a standardized test soil specifically developed to meet the requirements of ASTM F3208-20, the standard guide for validating cleaning processes for reusable medical devices.

This product is engineered to simulate the physicochemical behavior of real blood contamination while offering enhanced consistency and repeatability due to its non-clotting characteristics, making it highly suitable for controlled laboratory validation studies.

Why Biochemazone® Defibrinated Blood Soil is the Best Choice

Reusable medical devices like endoscopes, surgical tools, and suction tubes require rigorous cleaning validations to meet international regulations. Biochemazone® Defibrinated Blood Soil ASTM F3208-20 stands out with its unmatched quality, precision, and compliance with FDA, AAMI, ISO, and Health Canada guidelines.

With this test soil, you can effectively simulate blood-based contaminants such as hemoglobin, proteins, and lipids, ensuring your cleaning protocols meet the highest safety and performance standards.

If you are a medical device manufacturer, third-party reprocessor, or independent testing laboratory aiming to meet regulatory guidelines from agencies such as AAMI, FDA, CDC, Health Canada, CEN, and CSA, Biochemazone® Defibrinated Blood Soil ASTM F3208-20 offers an efficient and reliable solution. This advanced formulation is developed through detailed analysis of blood-based contaminants typically found on medical instruments after use, ensuring close replication of real-world conditions. The test soil contains biological materials such as hemoglobin, serum proteins, lipids, and electrolytes, making it ideal for validating reprocessing protocols in line with regulatory standards.

Real-World Simulation

Biochemazone’s Defibrinated Blood Soil ASTM F3208-20 replicates blood-based contaminants commonly found on reusable surgical instruments post-clinical use. The formulation includes hemoglobin (~2.5 mg/mL), serum proteins (~30–35 mg/mL), and lipids, accurately representing contamination levels observed in worst-case clinical scenarios. The absence of fibrin ensures consistent distribution and repeatability, supporting reliable validation of cleaning procedures as outlined by FDA and international regulatory requirements.

Ease of Use

Defibrinated Blood Soil ASTM F3208-20 is pre-formulated and ready to use, simplifying the process of assessing cleaning protocols for medical devices. Its non-clotting nature ensures smooth application and consistent coverage across device surfaces.

Versatile Applications

Defibrinated Blood Soil ASTM F3208-20 can be used across various applications, including:

Verifying cleaning protocols for reusable medical instruments
Assessing the effectiveness of reprocessing and decontamination methods
Testing removal of blood residues and organic contamination
Training staff in contamination detection and cleaning validation

The test soil can also be modified by adding endotoxins, microorganisms, or other biological agents to simulate post-use conditions more accurately.

Consistency and Stability

Unlike whole blood or fibrin-containing soils that may clot and vary between batches, Biochemazone’s Defibrinated Blood Soil ASTM F3208-20 ensures excellent batch-to-batch consistency. The formulation aligns with AAMI, ASTM, and ISO standards and follows FDA guidance for simulated-use testing. It offers a long shelf life and remains stable under recommended storage conditions.

Comprehensive Testing Solution

Biochemazone’s Defibrinated Blood Soil ASTM F3208-20 can be integrated with additional validation products to ensure a comprehensive evaluation of cleaning performance. This enables manufacturers to meet regulatory expectations by verifying the effective removal of blood-based residues through established protocols.

Why Choose Biochemazone Defibrinated Blood Soil ASTM F3208-20?

Simulates clinically relevant blood contaminants without clotting variability
Ready-to-use and easy to apply, minimizing preparation time
Provides reliable, reproducible results to support regulatory compliance and patient safety

Contact Us

For more information or to place an order, contact Biochemazone at:
📧 Email: info@biochemazone.com
🌐 Shipping: Available worldwide

Streamline your cleaning validation processes with Biochemazone’s Defibrinated Blood Soil ASTM F3208-20, ensuring consistent and reproducible results in compliance with global standards.

References

FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff. March 17, 2015. U.S. Department of Health and Human Services, Food and Drug Administration Publishers, Silver Spring, MD.

AAMI TIR12, Designing, testing and labeling reusable medical devices for reprocessing in health care settings: A guide for medical device manufacturers. AAMI TIR12 Technical Information Report 2010. Association for the Advancement of Medical Instrumentation (AAMI) Publishers.

AAMI TIR30. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. AAMI TIR30 Technical Information Report 2011. Association for the Advancement of Medical Instrumentation (AAMI) Publishers.

ASTM F3208-20 – Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

Biochemazone Other Artificial Test Soil Products:

Artificial Test Soil ASTM F3208-20
Artificial Test Soil with Bone
Artificial Blood Test Soil ASTM F3208-20
Artificial Blood Test Soil with Bone ASTM F3208-20
Dental Surgical Artificial Test Soil ASTM F3208-20
Saliva Artificial Test Soil ASTM F3208-20
Simulated Mucus Test Soils ASTM F3208-20
Simulated Ophthalmic Test Soil ASTM F3208-20
British Standard Soil
Miles Test Soil
Artificial Mucus Soil
Artificial Test Soil ISO 15883-5
Washer Disinfector Soil Test

Why Choose Soil Test ASTM F3208-20?

Reusable medical devices, such as endoscopes and surgical instruments, are exposed to complex biological soils during clinical use. If inadequately cleaned, these contaminants can interfere with disinfection, sterilization, and device performance, posing risks to patients and healthcare workers. Biochemazone® Soil Test ASTM F3208-20 is meticulously formulated to simulate these contaminants, supporting accurate and reproducible cleaning validations.

Compliance and Standards:

This product aligns with the ASTM F3208-20 standard and is informed by ASTM F3208-19 guidelines. It also supports ISO/TS 15883-5 requirements by providing reliable methods for assessing cleaning efficacy through both visual and quantitative evaluation.

Artificial Soil Testing for Surgical Devices

Purpose of Artificial Soil Test

Validation of cleaning procedures
Simulation of real-world blood contamination
Reproducibility across laboratories

FDA Guidelines on Artificial Soil:

Should represent physical and chemical properties of blood-based contaminants
Must allow quantitative evaluation of residual organic matter
Devices must meet acceptable cleanliness thresholds

Composition of Defibrinated Blood Soil:

Proteins:

Hemoglobin and serum proteins
Mimic blood residues

Lipids:

Simulate fatty biological components

Electrolytes:

Represent physiological ionic conditions

Optional Additives:

Microbial simulants or endotoxins for advanced testing

Testing Procedure:

Contamination:
Apply defibrinated blood soil to simulate clinical exposure

Cleaning:
Use manual, ultrasonic, or automated cleaning methods

Analysis:
Evaluate residual contamination using protein assays, spectrophotometry, or visual inspection

Additional References

ANSI/AAMI ST98: Cleaning validation of health care products
BS EN ISO 15883-5: Washer-disinfectors — cleaning efficacy testing
ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

This keeps your format identical, improves product differentiation, and positions BZ538 clearly as a non-clotting, high-consistency blood soil alternative to BZ479.

Additional information

mL	100mL, 200mL, 500mL, 50mL

Important Notes

Research Use Only: Biochemazone™ materials are intended strictly for research and development purposes in laboratory and industrial settings.
No Refunds or Exchanges: All sales are final. Biochemazone™ does not permit exchanges or offer refunds under any circumstances.
Customs & Import Responsibilities: Customs clearance, duties, taxes, and tariffs are the sole responsibility of the consignee/importer. Biochemazone™ is not liable for delays, rejections, or any additional costs incurred during the customs process, and such issues will not justify order cancellations or refunds.
Order Cancellations: Once an order is placed, it cannot be cancelled. No refunds will be issued for cancelled or undelivered orders.
Indemnification: The buyer agrees to indemnify and hold harmless Biochemazone™, its affiliates, and personnel from any claims, damages, liabilities, or expenses arising from the use of its products or services.
Terms & Conditions: All orders and communications are subject to Biochemazone™’s standard Terms & Conditions.