Miles Test Soil (BZ486)

Miles Test Soil – Artificial Test Soil for Cleaning Validation of Reusable Medical Devices BZ486

Product Code: BZ486
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 Miles Test Soil BZ486 is an artificial test soil that simulates clinical contaminants for the cleaning validation of reusable medical devices. It is a blend of biological and synthetic components that replicates the residues left on a device after clinical use – proteins, hemoglobin and polysaccharides – and it is pre-mixed and sieved for a uniform composition.

BZ486 is used to evaluate cleaning protocols for surgical instruments, endoscopes and other reusable devices exposed to blood and protein residues, to test cleaning efficacy in laboratory and industrial settings, and to develop and optimize detergents and cleaning processes. It can be used together with other test soils to simulate complex contamination, and it supports validation work to FDA, ASTM and ISO guidance.

BZ486 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 ASTM F3208-20 soil with stated marker levels see Artificial Test Soil ASTM F3208-20 (BZ477); for washer-disinfector testing see Artificial Synthetic Test Soil ISO/TS 15883-5 (BZ489).

Two Versions to Select

• Dried Powder: The dry, sieved soil, to be prepared 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.

How to Use

1. Prepare the soil: make up the Dried Powder, or use the Premixed Ready to Use Formulation as supplied.
2. Soil the device: apply the test soil to the surfaces, joints and lumens to be challenged.
3. Clean: put the device through the cleaning procedure being validated.
4. Analyse: inspect the device and measure residual protein or hemoglobin against your acceptance criteria.

Key Features & Benefits

✅ Realistic Contaminant Simulation – Proteins, hemoglobin and polysaccharides
✅ Pre-Mixed and Sieved – Uniform composition for consistent results
✅ Versatile – Compatible with other test soils for complex contamination
✅ 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 exposed to blood and protein residues
• Surgical instruments
• Endoscopes

🔬 Residue Testing
• Cleaning efficacy in laboratory and industrial settings
• Protein and hemoglobin endpoints
• Visual inspection

🧼 Detergent Development
• Evaluation of cleaning agents
• Optimizing cleaning protocols
• Comparison of washer cycles

📋 Regulatory Support
• Validation work to FDA, ASTM and ISO guidance
• Routine verification
• Training

Typical Properties

• Composition: Blend of biological and synthetic components simulating proteins, hemoglobin and polysaccharides
• Form: Pre-mixed and sieved
• 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:

• Tailored Miles Test Soil blends for a particular test
• Combination with other test soils
• Custom pack sizes and bulk quantities

Frequently Asked Questions

What contaminants does Miles Test Soil simulate?
Blood, proteins, hemoglobin and polysaccharides – the residues commonly found on medical devices after clinical use.

Can I use it for surgical instruments and endoscopes?
Yes. It is designed for the cleaning validation of reusable medical devices such as surgical instruments and endoscopes.

Which version should I select?
Select the Dried Powder to prepare the soil yourself, or the Premixed Ready to Use Formulation to apply it as supplied.

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.

Ordering Information

BZ486 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.