1. What is the primary testing application of TRINITY V3?
The primary TRINITY V3 testing application is automated zone reading and calculation of antibiotic potency assays. This software follows USP/EP/BP/JP methods of antibiotic potency assays. The secondary (and optional) testing feature of TRINITY V3 is automated colony counting. This software conforms to US-FDA/CFSAN Bacteriological Analytical Manual (BAM) for the Aerobic Plate Count Method.
2. Does TRINITY V3 conform to 21 CFR Part 11 requirements for electronic signature records?
Yes. TRINITY V3 conforms to 21 CFR Part 11 requirements including:
- Three level access control with user ID and password (Read Only, Standard User, Administrator)
- Password expiration settings
- Minimum password and user ID length settings
- Secure, encrypted database
- User access log and data audit trails
- All changes to users, configuration, and system settings are logged
- All test results are marked with user ID, date and time
3. Why should I automate reading of my test assays?
TRINITY V3 reduces over 95% of the time involved in reading and calculating test results, and eliminates all transcription errors. This provides more consistent, accurate and reliable test results than manual measurements. TRINITY V3 provides an electronic record of raw data and results in a standard format with electronic tracking of changes, as required by many regulatory agencies.
4. Are IQ, OQ, PQ validation protocols and training certification included with purchase?
Yes. Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) validation documents are included with purchase. Validation protocols can be customized to meet each lab’s unique requirements.
5. How often does TRINITY V3 need to be calibrated?
Calibration is performed when TRINITY V3 is:
- Initially setup
- Moved to a new location
- Updated with new software
A calibration template verifies zone reading measurements and color reactions. The calibration process takes less than one minute.
6. Is a computer provided with TRINITY V3?
No. A computer should be supplied locally and must comply with the specifications below (Question #7). However, TRINITY V3 does include a built-in 21 inch touch-screen monitor.
7. What are the TRINITY V3 computer requirements?
- Pentium 4 or equivalent (minimum), Core 2 Duo or faster (recommended for optimal performance)
- 512 meg RAM (minimum), 2 gig RAM or higher (recommended for optimal performance)
- Windows Vista, Windows 7, Windows 8
- All Microsoft® Service Packs and Critical Updates must be applied
- Three (3) available USB ports
- Internet connection (strongly recommended)
- Surge protector
*No monitor is required as a 21 inch touch-screen monitor is built-in to TRINITY V3.
8. Can the TRINITY V3 computer be used for additional applications?
Yes. The computer can be used for multiple functions including TRINITY V3, LIS/LIMS, other software programs, email, internet etc. The touch-screen on the TRINITY V3 may also be used for multiple applications.
9. What training is provided with TRINITY V3?
Extensive training is provided and includes:
- Online Customer Support Center training videos
- Product Manual (hard copy and electronic)
- Keyword indexed help in the software
- Step-by-step instructions on-screen
- Training with TRINITY V3 product specialist via teleconference
10. What is included in TRINITY V3’s Service Contract?
- Live customer support by telephone and email (7 days/week)
- Complete hardware warranty
- All software updates with new TRINITY V3 product features
- System installation and setup (via telephone and email)
- IQ, OQ, PQ validation support (via telephone and email)
- Access to Online Customer Support Center
11. How long is the installation and setup process for TRINITY V3?
TRINITY V3 is typically setup in under one hour. Simple instructions are provided in the product manual and on-screen Help. Installation videos are also available at the Online Customer Support Center. Giles Scientific is available by email or telephone to assist with the installation and training process until the customer is completely satisfied.
12. Does TRINITY V3 require routine maintenance?
No. TRINITY V3 requires no routine maintenance as it contains no motors or moving parts, only solid-state digital electronics. Less than 3% of our image analysis systems require service in 5 years. TRINITY V3 is highly reliable and rarely the source of a problem. Giles Scientific live telephone technical support is available 7 days a week.
13. How often is TRINITY V3 software upgraded?
TRINITY V3 software upgrades occur about once per year via website download. Additional software upgrades are provided if significant product features have been added during the year. All software updates are included with the Annual Service Contract. All software upgrades are optional.
14. How fast does TRINITY V3 measure zones and count colonies?
Each plate is read instantly (less than 1 second), whether it is measuring zones or counting colonies.
15. Does TRINITY V3 save plate images?
Yes. An unlimited number of high resolution color digital test plate images may be saved permanently with test results in electronic format.
16. Can TRINITY V3 export test results to other programs?
Yes. Test results may be exported in text format, which can be read by other software programs.
17. Can a bar code reader be used with TRINITY V3?
Yes, a standard bar code reader can be used to input the "identifier number". This setup eliminates transcription errors associated with manual entry.
18. Do I have to change my current testing methods?
No. TRINITY V3 is designed to fit into your routine use without altering your current methods, materials, organisms, layout pattern and government documentation.
19. Can the test information input fields and the printout fields be modified by the user?
Yes. Users can modify the test information input fields and the printout format.
20. Is it necessary to remove labels and writing from the bottom of test plates?
Yes. We recommend placing labels on the side of test plates to prevent interference with image analysis. Do not put labels on the bottom of the plate. Write on plates with a fine point pen in red, green or yellow ink. Wide black writing may interfere with image analysis.
21. Are plates inserted one at a time into TRINITY V3?
Yes. Plates are inserted one at a time into the TRINITY V3 drawer. A mechanical plate stacker has been evaluated but added no benefit. A plate stacker would require added setup, potential mechanical breakdowns, and create safety and service/support issues.
22. Should plate lids be removed prior to reading?
Yes. Plate lids should be removed during reading to optimize the imaging quality.
23. Prior to a purchase, can I send sample digital plate images to Giles Scientific for analysis?
Yes. We encourage you to email digital pictures of your plates to us for analysis. After analysis, we provide direct feedback as to the accuracy of our reading. There is no cost for this service.
24. After a purchase, can I send sample difficult or unique digital plate images to Giles Scientific for analysis?
Yes. We encourage you to email digital pictures of your plates to us for analysis. After analysis, we provide direct feedback as to how to improve the accuracy of our automated reading, and in some cases we may be able to add or modify our software to optimize reading of your plates. There is no cost for this service as it is part of our Annual Service Contract.
II. Antibiotic Potency Zone Reading
1. What different antibiotic potency assay methods are read and calculated with TRINITY V3?
TRINITY V3 automates USP (United States Pharmacopoeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia), JP (Japanese Pharmacopoeia), AOAC (American Association of Analytical Chemists), US-CFR (Code of Federal Registry) and a custom single plate methods. Giles Scientific may also customize software for your unique method/procedure.
2. What size plates can be read?
TRINITY V3 automatically reads 90-100mm round plates.
3. Are zone diameters viewed on-screen?
Yes. All automated zone measurements are viewed on-screen.
4. Is plate to plate variation accounted and corrected for in USP method calculations?
Yes. Sometimes the depth of agar, temperature differences in an incubator, or other factors may result in conditions that should be corrected for in the calculations of sample concentrations. This is automatically performed by the standard sample layout and calculations in the USP methods.
5. What purpose does the standard curve graph serve? (USP only)
The standard curve graph is displayed on-screen to help the user visualize where the standard and unknown samples are plotted relative to the curve. The graph is not used for calculations; the calculations are performed by mathematical formulas.
6. Is there an option to automatically check for outliers? (USP only)
Yes. Each set of zone measurements can be automatically checked for outliers using the USP Outlier Test. Outlier values are marked on-screen and automatically excluded from calculated results.
7. Can samples be put onto paper disks, into wells cut in the agar, and into metal cylinders?
Yes. Liquid samples may be placed in any of these. Some method guidelines specify which of these may be used.
8. How many standard concentrations can I have?
The number of standard concentrations is defined in each published method.
9. Can a Peni Cylinder Dispenser be used with TRINITY V3?
Yes. A peni cylinder dispenser is recommended to drop 4 or 6 cylinders onto a Petri plate. This provides a more efficient workflow and accurate cylinder placement. Giles Scientific sells peni cylinders and peni cylinder dispensers. Learn more >
10. Are the 2012 USP <81> revisions included in TRINITY V3?
Yes. The latest USP <81> revisions were added to TRINITY V3 in July 2012 including:
- Calculation and display of relative standard deviation for each measurement set
- Added combined sample potency report
- Allows selection of individual samples to 1) Include checks for outliers in combined sample potency values 2) Log based combined average potency calculation 3) Confidence interval calculation for average potency.
III. Colony Counting
1. What types of colony count plates can be read automatically?
A variety of plate types and sizes can be read including: Plates up to 150mm in diameter, 3M™ Petrifilm™, Ames assays, phage/plaque assays, pour plates, spiral inoculated plates, filter membrane agar plates (with or without printed grids), and chromogenic agars.
2. Can the colonies be counted when there is food or debris in the agar?
Yes. Most food and debris are distinguished from colonies by color and/or size.
3. Can blood and dark colored agar be read?
Yes. Clear, opaque, blood and dark colored agar can be read. TRINITY V3 contains a closed cabinet with upper and lower LED lighting for both light and darkfield, or combined. A closed cabinet (drawer) is critical for difficult reading situations.
4. Can touching and overlapping colonies be divided into separate counts?
Yes. Colonies that are touching or overlapping can be separated by size and shape into multiple counts automatically. Large colonies may be divided into multiple counts based on a flexible size variable. These settings can be turned on or off. These colonies can also be manually added or deleted from the automated count using the touch-screen or mouse click.
5. What is the smallest detectable colony read?
The smallest detectable colony is 0.05mm and smallest colony size discrimination is 0.08mm.
6. Can plates that are divided into several segments be read automatically?
Yes. Entire plate, half-plates, quadrants, or custom defined areas can be read. Each plate segment is counted independently in addition to total plate count.
7. Are colonies differentiated based on size?
Yes. Colonies may be differentiated based on size. Up to 10 size ranges can be defined and counted simultaneously. Counted colonies may be differentiated based on color similarities with user adjustable color ranges. One or any number of user-defined colors can be counted as well.
|Testing Modules:||Accessories & Features:||Methods:||Resources:|
|-Antibiotic Potency Zone Reading||-Peni Cylinders||-USP||-Customer Testimonials|
|-Colony Counting||-Peni Cylinder Dispenser||-EP/BP||-Current Customers|
|-21 CFR Part 11||-JP||-Common Questions|
|-IQ OQ PQ Validation||-Large Plate||-Quick Tour Video|
|-Training & Support||-Brochures|