Simulated Mucus Test Soil ASTM F3208-20 – Worst-Case Mucus Soil for Endoscopes and Respiratory Devices BZ483
Product Code: BZ483
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 Simulated Mucus Test Soil BZ483 is formulated to simulate the mucus of cystic fibrosis patients, which represents a worst case for cleaning. It is an artificial test soil for the cleaning validation of reusable medical devices that come into contact with mucus in clinical use, in line with ASTM F3208-20. The soil uses a modified cystic fibrosis mucus formulation with a high mucin concentration, together with casein hydrolysate, DNA, egg yolk emulsion and salts.
Thick mucus clings to surfaces and blocks narrow channels. BZ483 is used for the simulated-use soiling and cleaning validation of flexible endoscopes, respiratory equipment and other reusable devices used in high-mucus environments such as the gastrointestinal tract and the lungs, and for developing and validating detergents and cleaning protocols. It can be combined with other test soils, such as a blood soil, to simulate the mixed soiling a flexible endoscope meets.
BZ483 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 exposed to mucus and blood in ENT procedures see British Standard Soil (BZ485); to add blood see Defibrinated Blood Soil.
Two Versions to Select
- Dried Powder: Dry components that 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.
Constituents (Modified Cystic Fibrosis Mucus Formulation)
- Mucin from pig mucosa: 1000 mg
- Casein hydrolysate: 500 mg
- Sodium chloride (NaCl): 500 mg
- Potassium chloride (KCl): 500 mg
- Diethylene triamine pentaacetic acid (DTPA): 0.59 mg
- Salmon sperm DNA: 140 mg
- Freeze-dried egg yolk emulsion: 232 mg
- Phosphate buffered saline (PBS) without calcium and magnesium: 8.5 mL
- ASTM Type 1 water (Specification D1193): 80 mL
How to Use
- Prepare the soil: reconstitute the dry components, or use the Premixed Ready to Use Formulation as supplied. For mixed soiling, combine it with a blood soil.
- Soil the device: apply the test soil to the surfaces and channels that meet mucus in clinical use.
- Clean: put the device through the cleaning procedure being validated.
- Analyse: inspect the device and measure the residual soil against your acceptance criteria.
Key Features & Benefits
✅ Worst-Case Mucus – Modified cystic fibrosis mucus formulation with a high mucin concentration
✅ Stated Constituents – Mucin, casein hydrolysate, DNA, egg yolk emulsion, salts and DTPA
✅ ASTM F3208-20 – For cleaning validation of reusable medical devices
✅ Combinable – Can be mixed with blood soils for complex clinical soiling
✅ 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
✅ Made in Canada – Manufactured under ISO 9001 / GMP quality systems
Applications
🫁 Respiratory Equipment
• Reusable respiratory devices
• Devices used in the pulmonary system
• High-mucus environments
🔦 Flexible Endoscopes
• Gastrointestinal endoscopes
• Channels and lumens
• Mixed mucus and blood soiling
🏥 Cleaning Validation
• Simulated-use soiling
• Worst-case cleaning scenarios
• Reprocessing instructions
🧼 Detergent Development
• Development of detergents
• Validation of cleaning protocols
• Comparison of cleaning cycles
Typical Properties
- Composition: Mucin from pig mucosa, casein hydrolysate, sodium chloride, potassium chloride, DTPA, salmon sperm DNA, freeze-dried egg yolk emulsion, PBS and ASTM Type 1 water
- Basis: Modified cystic fibrosis mucus formulation
- Standard: ASTM F3208-20
- 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 within two weeks; do not return unused soil to the container
Customization Options
Customization available on request:
- Combination with a blood soil for mixed soiling
- Custom formulations for a particular device
- Custom pack sizes and bulk quantities
Frequently Asked Questions
Why is cystic fibrosis mucus used as the model?
It is thicker and more tenacious than normal mucus, with a high mucin and DNA content, so it represents the worst case a cleaning process is likely to meet. A process that removes it gives a margin of safety for ordinary mucus.
Can BZ483 be combined with blood?
Yes. It can be combined with other test soils to simulate complex clinical soiling, for example on flexible endoscopes exposed to gastrointestinal and vascular contaminants. See Defibrinated Blood Soil.
Which version should I select?
Select the Dried Powder to prepare the soil fresh, or the Premixed Ready to Use Formulation to save preparation time.
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
BZ483 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.
