Artificial Test Soil with Bone (BZ478) – ASTM F3208-20

Artificial Test Soil with Bone ASTM F3208-20 – for Devices That Come into Contact with Bone BZ478

Product Code: BZ478
Manufacturer: Biochemazone
Available Pack Sizes: Dried Powder: 5 g, 10 g, 20 g, 50 g – for making 50 mL, 100 mL, 200 mL, 500 mL · Premixed Ready to Use Formulation: 50 mL, 100 mL, 200 mL, 500 mL
Custom Bulk Quantities Available

Product Overview

Biochemazone Artificial Test Soil with Bone BZ478 is a test soil for the simulated-use soiling of medical devices that come into contact with bone, for cleaning validation studies in line with ASTM F3208-20. The reconstituted soil contains proteins, hemoglobin, carbohydrates, lipids, insoluble fibres and bone particulates – the contaminants found on surgical instruments after clinical use – with protein at 23 mg/mL, hemoglobin at 8 mg/mL and carbohydrate at 6 mg/mL.

Bone particulates lodge in the flutes, teeth, hinges and lumens of an instrument and are harder to remove than a liquid soil. BZ478 puts that challenge into the validation: it is used by manufacturers of instruments that cut, drill or handle bone, by reprocessors and by test laboratories to validate cleaning instructions and to compare detergents and cleaning cycles. The formulation contains purified bovine proteins (hemoglobin and albumin), physiological salts, mucin, gum, egg yolk, cellulose and bone particulates.

BZ478 can be ordered as Dried Powder or as a Premixed Ready to Use Formulation – the powder in 5 g, 10 g, 20 g and 50 g packs for making 50 mL, 100 mL, 200 mL and 500 mL, and the premixed formulation in 50 mL, 100 mL, 200 mL and 500 mL packs. The dried powder has a 2-year shelf life and can be reconstituted easily. Unopened, it has a 2-year shelf life at 2–30 °C and is shipped at room temperature. For the soil without bone see Artificial Test Soil ASTM F3208-20 (BZ477); for bone with blood see Artificial Blood Test Soil with Bone (BZ480).

Two Versions to Select

• Dried Powder: Supplied as dry vials – the dry test soil mix and the mixture of proteins, salts, mucin, gum, egg yolk, cellulose and bone particulates – which are reconstituted before the test.
• Premixed Ready to Use Formulation: Supplied mixed and ready to apply, with no weighing or mixing.

Select the version first and then the pack size. The Dried Powder has a 2-year shelf life and can be reconstituted easily: 5 grams is for making 50 mL, 10 grams is for making 100 mL, 20 grams is for making 200 mL and 50 grams is for making 500 mL. The Premixed Ready to Use Formulation is supplied in 50 mL, 100 mL, 200 mL and 500 mL packs.

Composition and Marker Levels

• Purified bovine proteins: hemoglobin and albumin
• Physiological salts, mucin, gum, egg yolk and cellulose
• Bone particulates
• Protein: 23 mg/mL; hemoglobin: 8 mg/mL; carbohydrate: 6 mg/mL (reconstituted soil)
• Optional: 20% defibrinated sheep blood can be added after reconstitution for a closer simulation

How to Use

1. Prepare the soil: reconstitute the dry vials, or use the Premixed Ready to Use Formulation as supplied. Mix well so that the bone particulates are evenly distributed.
2. Soil the device: apply the test soil to the surfaces, joints and lumens that contact bone in clinical use.
3. Clean: put the device through the cleaning procedure being validated.
4. Analyse: inspect for remaining particulates and measure residual protein, hemoglobin or carbohydrate against your acceptance criteria.

Key Features & Benefits

✅ Bone-Specific Simulation – Bone particulates with proteins, hemoglobin, carbohydrates, lipids and insoluble fibres
✅ Clinically Relevant Markers – Protein 23 mg/mL, hemoglobin 8 mg/mL, carbohydrate 6 mg/mL
✅ ASTM F3208-20 – For simulated-use testing in cleaning validation studies
✅ Two Versions to Select – Dried Powder (5 g to 50 g, for making 50 mL to 500 mL) or Premixed Ready to Use Formulation
✅ 2-Year Shelf Life – Unopened at 2–30 °C; shipped at room temperature
✅ Reproducible & Standardized – Consistent batch-to-batch composition for routine QC and inter-laboratory comparison
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems

Applications

🦴 Instruments That Contact Bone
• Devices that cut, drill or handle bone
• Hinged, fluted and lumened instruments
• Simulated-use soiling

🏥 Cleaning Validation
• Validation of reprocessing instructions
• Worst-case soil with particulates
• Protein, hemoglobin and carbohydrate endpoints

🧼 Detergents & Washers
• Comparison of cleaning agents
• Washer-disinfector and ultrasonic cycles
• Manual brushing and flushing steps

🔬 Laboratories & R&D
• Independent test laboratories
• Design verification of new instruments
• Training in cleaning validation

Typical Properties

• Composition: Purified bovine proteins (hemoglobin, albumin), physiological salts, mucin, gum, egg yolk, cellulose and bone particulates
• Markers (reconstituted): Protein 23 mg/mL; hemoglobin 8 mg/mL; carbohydrate 6 mg/mL
• Standard: ASTM F3208-20
• Versions: Dried Powder (dry vials); Premixed Ready to Use Formulation
• Dried Powder packs: 5 g, 10 g, 20 g, 50 g – for making 50 mL, 100 mL, 200 mL, 500 mL
• Premixed Ready to Use Formulation packs: 50 mL, 100 mL, 200 mL, 500 mL

Storage, Shelf Life & Transportation

• Storage Temperature: 2–30 °C, in the tightly closed container, protected from light and moisture
• Transportation: At room temperature
• Shelf Life: 2 years (unopened)
• Versions: Dried Powder and Premixed Ready to Use Formulation – the 2-year shelf life applies to both, unopened
• Dried Powder: 2-year shelf life and easy to reconstitute – 5 grams is for making 50 mL, 10 grams for 100 mL, 20 grams for 200 mL and 50 grams for 500 mL
• Protein-Containing Product: The Premixed Ready to Use Formulation is best kept at 2–8 °C for prolonged storage and stability; storage at 2–30 °C is fine for short-term use
• After Reconstitution or Opening: Refrigerate and use within two weeks; do not return unused soil to the container

Customization Options

Customization available on request:

• Soil with 20% defibrinated sheep blood
• Custom formulations for a particular device or procedure
• Custom pack sizes and bulk quantities

Frequently Asked Questions

Why does a bone-contact device need its own test soil?
Bone particulates behave differently from a liquid soil: they pack into flutes, teeth, hinges and lumens. A soil with bone particulates tests whether the cleaning process removes them as well as the protein and blood residues.

How does BZ478 differ from BZ477?
Artificial Test Soil ASTM F3208-20 (BZ477) is the general soil for surgical instruments. BZ478 adds bone particulates and has a different marker profile – 23 mg/mL protein, 8 mg/mL hemoglobin and 6 mg/mL carbohydrate.

Can blood be added?
Yes. 20% defibrinated sheep blood can be added after reconstitution for a closer simulation. For a soil formulated with blood see Artificial Blood Test Soil with Bone (BZ480).

How should it be stored, and how long does it keep?
Store it at 2–30 °C in the tightly closed container, protected from light. It is shipped at room temperature, and unopened both versions have a 2-year shelf life. Because the soil contains proteins, the premixed version is best kept at 2–8 °C if it will be stored for a long time. Once the powder is reconstituted or the premixed soil is opened, refrigerate it and use it within two weeks.

Ordering Information

BZ478 is available in standard laboratory sizes or OEM/bulk supply formats.

📄 MSDS, Technical Datasheet, and Certificate of Analysis (CoA) available upon request
📧 Email: info@biochemazone.com
🌐 Website: www.biochemazone.com

⚠️ For research, education, and in vitro testing only. Not for human or animal use.