Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480) – ASTM F3208-20: The Ultimate Solution for Cleaning Validation

Ensuring the cleanliness of reusable medical devices is a critical aspect of healthcare. Without proper validation of cleaning processes, residual contaminants can compromise patient safety and interfere with sterilization protocols. To address this challenge, Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480) – ASTM F3208-20 offers a scientifically formulated test soil designed to simulate real-world clinical contaminants. This product is essential for cleaning validation and verification studies, supporting compliance with industry regulations and enhancing patient safety.

What is Artificial Blood Test Soil with Bone (BZ480)?

Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480) is a blood protein-based standardized test soil developed to meet the stringent requirements of ASTM F3208-20. This standard serves as a guide for evaluating cleaning processes for reusable medical devices. The formulation closely mimics contaminants found on surgical instruments, endoscopes, and other reusable medical devices, ensuring reliable testing conditions.

Unlike generic test soils, BZ480 includes a precise blend of biological and non-biological constituents, such as:

• Purified bovine hemoglobin and albumin (representing blood proteins)
• Polysaccharides and lipids (simulating organic matter)
• Insoluble fibers and bone particles (representing tissue and bone debris)

This sophisticated composition allows researchers, medical device manufacturers, and healthcare facilities to accurately validate cleaning efficacy.

Key Features of Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480)

1. Realistic Clinical Contaminant Simulation

The BZ480 formulation is engineered to mimic contaminants encountered during clinical use. It replicates blood residues, proteins, lipids, and bone fragments, providing real-world testing conditions for medical device cleaning validations.

2. Compliance with ASTM F3208-20

This test soil adheres strictly to ASTM F3208-20 standards, ensuring reproducible and standardized testing conditions. Compliance with this guideline is crucial for regulatory acceptance and consistent validation protocols.

3. Optimized Physical Properties

The viscosity, adhesion, and composition of BZ480 closely match actual biological contaminants. This ensures that medical devices undergo a realistic and effective cleaning validation process.

4. Safe and Stable Formula

• Non-hazardous and environmentally friendly
• Supplied as a reddish-brown powder and clear liquid for easy reconstitution
• Stable for 12 months under recommended storage conditions

5. Ready-to-Use and Customizable Options

BZ480 is available in various packaging sizes, including 50 mL, 100 mL, 200 mL, and 500 mL, catering to different testing needs. Bulk and custom formulations are also available upon request.

Applications of BZ480 in Cleaning Validation

The Artificial Blood Test Soil with Bone (BZ480) plays a crucial role in medical device cleaning validation across multiple applications:

1. Validation of Cleaning Processes for Medical Devices

• Used in testing the efficacy of cleaning protocols for surgical instruments, endoscopes, suction tubes, and other reusable medical devices.
• Helps ensure that no biological residue remains post-cleaning.

2. Performance Testing of Detergents and Cleaning Agents

• Evaluates the effectiveness of various enzymatic cleaners, detergents, and disinfection solutions.
• Helps compare different cleaning agents for optimal performance in contamination removal.

3. Automated Cleaning Systems Testing

• Supports testing of ultrasonic cleaners, washer-disinfectors, and automated decontamination systems.
• Ensures that automated processes meet regulatory standards.

4. Research & Development

• Facilitates the development of innovative cleaning technologies.
• Provides an accurate simulation of clinical contaminants for product testing.

5. Training and Compliance Programs

• Used in training programs for hospital staff, ensuring effective contamination detection and cleaning validation.
• Supports compliance with FDA, AAMI, ISO, and Health Canada guidelines.

Product Specifications

Physical Composition

• Dry Component: Reddish-brown powder
• Aqueous Component: Clear liquid

Chemical Composition

• Proteins: Purified bovine hemoglobin and albumin
• Carbohydrates and Lipids: Simulating organic contaminants
• Bone Particles and Insoluble Fibers: Mimicking real-world clinical contaminants

Storage and Shelf Life

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

How to Use Biochemazone™™ BZ480 for Cleaning Validation

1. Reconstitution Process

• Mix the dry and aqueous components to prepare the artificial blood test soil.
• Ensure proper homogenization before application.

2. Application on Medical Devices

• Apply the BZ480 mixture onto the medical device surface, ensuring full coverage.
• Allow the test soil to dry, simulating realistic contamination scenarios.

3. Cleaning Procedure Validation

• Subject the device to the intended cleaning method (manual, automated, or enzymatic).
• Inspect the removal of contaminants to assess cleaning efficacy.

4. Post-Cleaning Analysis

• Evaluate cleaning results using residual protein analysis, visual inspection, and chemical detection methods.
• Adjust cleaning protocols if necessary to achieve regulatory compliance.

Why Choose Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480)?

Choosing Biochemazone™™ BZ480 ensures:

✔ Accurate and reproducible validation of cleaning protocols
✔ Compliance with ASTM F3208-20 and other global standards
✔ Realistic clinical contamination simulation for reliable testing
✔ Batch-to-batch consistency for standardized evaluations
✔ Customizable solutions to meet specific research and industry needs

Biochemazone™™ is committed to enhancing the safety and efficacy of medical device cleaning validation. With the BZ480 Artificial Blood Test Soil, researchers, manufacturers, and healthcare professionals can achieve unparalleled precision in contamination removal assessments.

For more information or to place an order, visit the product page:
👉 Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480) – ASTM F3208-20

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If you need additional assistance or bulk purchasing inquiries, contact Biochemazone™™ Customer Support at info@biochemazone.com.

By integrating Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480) into your validation processes, you ensure higher standards of cleanliness, regulatory compliance, and enhanced patient safety.

Frequently Asked Questions (FAQs)

1. What exactly is Biochemazone™™ Artificial Blood Test Soil with Bone (BZ480), and why is it important?

Simply put, BZ480 is a lab-made substitute for the real grime that builds up on medical instruments after use. It’s designed to simulate blood, proteins, fat, and even bone particles, so when you test cleaning methods on it, you’re getting results that are as close to real-world contamination as possible.

If hospitals and manufacturers don’t properly validate their cleaning processes, leftover biological material can interfere with sterilization—or worse, lead to infections. That’s why products like BZ480 are crucial for ensuring cleaning protocols actually work.

2. What makes BZ480 different from other test soils?

Unlike generic test soils, BZ480 doesn’t just simulate “dirt”—it’s specifically formulated to match the composition and behavior of real human blood, proteins, and bone debris. It’s built to comply with ASTM F3208-20, which is the industry standard for cleaning validation.

That means if your cleaning process works against BZ480, you can trust that it’s working against actual surgical contaminants. Other test soils might not have the same level of realistic adhesion, viscosity, or protein breakdown properties, making them less reliable for serious testing.

3. Can I use BZ480 for testing automated cleaning systems?

Absolutely. It’s widely used in:

• Washer-disinfectors (the big machines hospitals use to clean instruments)
• Ultrasonic cleaning systems
• Enzymatic and detergent-based cleaning processes
• Automated endoscope reprocessors (AERs)

Because BZ480 behaves like real surgical contaminants, it’s ideal for seeing whether an automated system is truly removing biological residue.

4. How should I store BZ480 to keep it effective?

BZ480 is pretty stable, but for best results:

• Dry Powder – Store at room temperature in a sealed container.
• Reconstituted Solution – Keep at 2°C–8°C (refrigerated) and use within two weeks.
• Avoid direct sunlight and extreme heat, as that can mess with its composition.

If stored properly, BZ480 has a shelf life of up to 12 months before opening.

5. Is BZ480 safe to handle?

Yes, it’s non-toxic and environmentally safe, but remember—it’s designed to act like blood and other biological contaminants, so treat it like you would real clinical soil. Wear gloves and protective eyewear, especially when working in a lab environment. It’s not hazardous, but good lab hygiene is always a must.

6. What pack sizes are available?

BZ480 is available in:
✔ 50 mL
✔ 100 mL
✔ 200 mL
✔ 500 mL
✔ Bulk orders available upon request

Whether you’re running a small-scale validation test or a full-blown industrial cleaning study, there’s an option that fits.

7. How do I apply BZ480 for a cleaning validation test?

It’s super simple:

1. Reconstitute the test soil by mixing the dry powder with the liquid component.
2. Apply it to your medical device (either manually or by immersion).
3. Let it dry—this is important because real contaminants aren’t always fresh; they dry onto surfaces.
4. Run the device through your cleaning process (manual washing, enzymatic soaking, or automated disinfection).
5. Check the results—use protein residue tests, visual inspection, or chemical analysis to see if it was completely removed.

If the test soil isn’t fully cleaned off, you know you need to tweak your process.

8. How do I order Biochemazone™™ BZ480?

You can buy it directly from Biochemazone™’s official website. If you need bulk orders or custom formulations, you can reach out to Biochemazone™ Customer Support at info@biochemazone.com.