Artificial Test Soil ASTM F3208-20 – for Cleaning Validation of Reusable Medical Devices BZ477
Product Code: BZ477
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 ASTM F3208-20 BZ477 is a standardized test soil for validating the cleaning of reusable medical devices. ASTM F3208-20 is the Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices, and BZ477 is formulated in line with it, from the analysis of the contaminants found on medical instruments after use. It contains proteins, hemoglobin, carbohydrates, mucin, cellulose and lipids, with approximately 33 mg/mL protein, 2.5 mg/mL hemoglobin and 11 mg/mL carbohydrate – contamination levels that represent a worst case.
A device is soiled with BZ477 and put through its cleaning process; the residue left behind is then inspected visually or measured as protein, hemoglobin or carbohydrate. Medical device manufacturers, third-party reprocessors and independent test laboratories use it to validate reprocessing instructions for endoscopes, surgical instruments and suction tubes, to compare detergents and washer-disinfector cycles, and to train staff. Unlike collected biological material, it has the same composition in every batch, and it can be modified by adding endotoxins, microorganisms or other biological agents.
BZ477 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 devices that contact bone see Artificial Test Soil with Bone (BZ478); for a soil with blood see Artificial Blood Test Soil (BZ479); for washer-disinfector testing to ISO 15883-5 see Artificial Synthetic Test Soil ISO/TS 15883-5 (BZ489).
Two Versions to Select
- Dried Powder: Dry mix that stays stable at room temperature and is reconstituted before the test – suited to laboratories that prepare the soil fresh for each study.
- 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.
Marker Levels (Ready-to-Use Soil)
- Protein: approximately 33 mg/mL
- Hemoglobin: approximately 2.5 mg/mL
- Carbohydrate: approximately 11 mg/mL
- Also contains mucin, cellulose and lipids
How to Use
- Prepare the soil: reconstitute the Dried Powder, or use the Premixed Ready to Use Formulation as supplied.
- Soil the device: apply the test soil to the device so as to mimic the conditions of clinical use.
- Clean: put the device through the cleaning procedure being validated – manual cleaning, ultrasonic cleaning or an automated washer.
- Analyse: evaluate the residual soil by visual inspection, spectrophotometry or a protein assay, against your acceptance criteria.
Key Features & Benefits
✅ ASTM F3208-20 – Formulated in line with the standard guide for selecting test soils for reusable medical devices
✅ Clinically Relevant Markers – Approx. 33 mg/mL protein, 2.5 mg/mL hemoglobin and 11 mg/mL carbohydrate
✅ Worst-Case Soil – Proteins, hemoglobin, carbohydrates, mucin, cellulose and lipids
✅ 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
🏥 Cleaning Validation
• Reusable medical devices such as endoscopes, surgical instruments and suction tubes
• Validation of reprocessing instructions
• Simulated-use testing
🧼 Detergents & Washers
• Comparison of cleaning agents
• Washer-disinfector and ultrasonic cycles
• Manual cleaning procedures
🔬 Residue Analysis
• Protein, hemoglobin and carbohydrate endpoints
• Visual inspection after cleaning
• Assessment of residual risk
🎓 Research & Training
• Development of cleaning and sterilization technologies
• Training in contamination detection
• Soils modified with endotoxins or microorganisms
Typical Properties
- Composition: Proteins, hemoglobin, carbohydrates, mucin, cellulose and lipids
- Markers: Protein approx. 33 mg/mL; hemoglobin approx. 2.5 mg/mL; carbohydrate approx. 11 mg/mL
- Standards: ASTM F3208-20; ISO/TS 15883-5
- Versions: Dried Powder; 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 promptly; do not return unused soil to the container
Customization Options
Customization available on request:
- Soil modified with endotoxins, microorganisms or other biological agents
- Custom formulations for a particular device or procedure
- Custom pack sizes and bulk quantities
Frequently Asked Questions
What does BZ477 simulate?
The organic contamination left on reusable surgical instruments after clinical use. It contains proteins, hemoglobin, carbohydrates, mucin, cellulose and lipids at levels that represent a worst case, so a cleaning process that removes it has been challenged realistically.
Which version should I select?
Select the Dried Powder if you prefer to prepare the soil fresh for each study and keep stock on the shelf; it stays stable at room temperature until it is reconstituted. Select the Premixed Ready to Use Formulation to save preparation time.
Which endpoints can I measure after cleaning?
The soil carries protein, hemoglobin and carbohydrate markers, so residues can be quantified with the usual assays for these, in addition to visual inspection.
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 promptly.
Standards and Guidance Referred To
- ASTM F3208-20 – Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
- ISO 15883-5 – Washer-disinfectors: performance requirements and test method criteria for demonstrating cleaning efficacy
- ANSI/AAMI ST98 – Cleaning validation of health care products
- FDA Guidance (2015) – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Ordering Information
BZ477 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.
