Rapid Screening of Products for Microbial Contamination .fr
Quantitative. â Qualitative. ⢠Automated, high throughput analysis with continuous processing capability. ⢠Reagents stable at room temperature for 7 days.
Rapid Screening of Products for Microbial Contamination Ann Steger, Advanced Analytical
Presentation Overview • Advanced Analytical Overview • The Micro PRO™ Detection System • Product Screening Procedure & Results • The Advanced Analytical Solution
Advanced Analytical Mission Statement: Through innovative technology and collaborative relationships we will: • Deliver superior customer support, services, and solutions • Create sustainable growth • Foster a dynamic and fulfilling work environment
Microbiology Solution: Replace current microbiological methods requiring 1 to 7 days with an automated system that provides rapid detection and enumeration
Capillary Electrophoresis (CE) Solution: Provide high throughput analysis systems for drug/chemical compounds, oligonucleotide purity analysis, and protein separation
DNA PRO-filer
Global Distribution • North America • Europe • Asia • Australia/New Zealand • South America
The Micro PRO™ Specialized Technology for Rapid Microbial Detection
Features of the Micro PRO™ System •
Versatile system – –
Quantitative Qualitative
•
Automated, high throughput analysis with continuous processing capability
•
Reagents stable at room temperature for 7 days
•
Differentiate microorganism type
•
Objective results – –
•
Counts/mL Pass/Fail
21 CFR part 11-compliant software
Analysis on the Micro PRO™ System
1
3
Load sample vials and syringes
2
Reagent additions and sample injection performed automatically
Micro PRO™ Pass/Fail Result Enriched sample w/ microbes
Microbes labeled
Flow Cytometry-Based Technology • Laser-based excitation at 635nm • Fluorochromes bound to cells provide information on cell state • Live/dead • Spores/vegetative
• Light scattering provides relative size information • Provides quantification of microorganisms in counts/mL • System composed of fluidic, optic and electronic components
Fluidic System Sample delivery
Sheath delivery
Sheath flow Labeled microbes
Core flow
• Quantitative cell delivery • Hydrodynamic Focusing • Single File Passage through detection region
Optic System Labeled microorganism
Scatter Detector
Fluorescence Detector
Scatter signal Fluorescence signal
High performance optical filters
Fluorescence plus Scatter = One Count
Laser Beam – shaped and focused; 635 nm laser excitation
Electronic System • • • •
Signal processing component The Micro PRO™ triggers on fluorescence Fluorescence Threshold decreases low-level noise Fluorescent event above the threshold is processed, along with associated scatter event • Plotted on graph and recorded as a count
Detector output
= 1 count = 0 count Time
Fluorescence Threshold Level
Example of Micro PRO™ Intensity Plot
Cell size
Amount of label
Rapid Product Screening One Test...One Solution
One Test...One Solution for Product Screening • Detect bacteria, yeast & mold in 1 test • Product Types: Personal & Oral Care OTC Pharma Cosmetics Excipients
Household Nutraceutical Beverage
• Various Matrices: liquids gels emulsions ointments
powders tablets natural extracts
• Complete Kit with media & consumables
Traditional method USP Bacteria 1:10 dilution of product
1mL in each of two Petri dishes with Soybean Casein Digest
Incubate 48 to 72 hours at 30°C
Count
Yeast and Mold 1:10 dilution of product
1mL in each of two Petri dishes with Saboraud Dextrose Agar
Transfer substrate tube A to Tube B; vortex; 0.1mL to Tube C
Micro PRO™
Micro PRO™ Media Kit • All-inclusive kit containing tubes pre-filled with enrichment media and buffer • Specialized media & substrate for enhanced mold growth • Protocol minimizes product baselines and increases sensitivity
Experimental Procedure 1. Prepared 1:10 product suspension in buffer or neutralizing growth enhancement media 2. Added 1mL 1:10 product suspension to Tube A & neutralized 30 min 3. Spiked with 3X product baseline) • Fail result indicates that the sample contains microbial contamination Mold counts/mL
Bacteria counts/mL
212002
648372
Bacteria
Mold Yeast counts/mL Result 1 28379
Fail
Bacteria Result 2
Yeast Result 3
Overall Result
Fail
Fail
Fail
Mold counts/mL
Bacteria counts/mL
43
1913
Mold Yeast counts/mL Result 1 1770
Pass
Bacteria Result 2
Yeast Result 3
Overall Result
Pass
Fail
Fail
Bacteria Result 2
Yeast Result 3
Overall Result
Pass
Pass
Fail
Yeast
Mold counts/mL
Bacteria counts/mL
2452
2144
Mold
Mold Yeast counts/mL Result 1 65
Fail
Results Summary Personal Care Products
Enrichment Time – Positive for Bacteria, Yeast & Mold
Face scrub
24 hrs
Hair gel
24 hrs
Hand soap, antibacterial
24 hrs
Lotion
24 hrs
Mouthwash
24 hrs
Shampoo
24 hrs
Shave gel
24 hrs
Sunscreen
24 hrs
Toothpaste
30 hrs
Results Summary OTC Pharmaceuticals
Enrichment Time – Positive for Bacteria, Yeast & Mold
Acetaminophen
24 hrs
Ibuprofen
24 hrs
Antacid tablets
24 hrs
Anti-itch cream
24 hrs
Nasal spray
24 hrs
Sleep aid capsules
24 hrs
Cold/flu liquid
24 hrs
Allergy liquid
24 hrs
Multivitamins
24 hrs
Fiber capsules & powder
48 hrs
Results Summary Others
Enrichment Time – Positive for Bacteria, Yeast & Mold
Excipients
24 hrs
Household cleaner
24 hrs
Industrial Emulsions
24 hrs
Antioxidant water
24 hrs
Cranberry juice
24 hrs
Lemonade
24 hrs
Vegetable juice
48 hrs
The Advanced Analytical Solution Provides: • One test for the detection of bacteria, yeast & mold in a variety of matrices • Rapid screening for microbial contamination with 24 hour results for a majority of the products tested • Objective Pass/Fail results requiring no additional interpretation • Pass/Fail criteria that generate no false positives or false negatives • Versatile system for quantification of microorganisms in purified water, surface swabs, and pure cultures
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