PyroGel - FAQ

1. What is PyroGel?
2. Is PyroGel 21 CFR Part 11 compliant?
3. What is PyroTherm?
4. What are the main advantages of the PyroTherm compared to the water bath?
5. Can I use PyroTherm for other applications?
6. What is a EQU & EQUAL?
7. How does EQUAL work?
8. What kind of database does PyroGel use?
9. Does PyroGel support documentation of the reagents, supplies and equipment used during a measurement?
10. Is PyroGel validated?
11. How does PyroGel register the temperature?
12. What kind of support will I receive after purchase?
13. What kinds of gel-clot methods are supported in PyroGel?
14. Why should I buy PyroGel?

1. What is PyroGel?
   PyroGel is the first integrated program for computer aided gel-clot testing. The software controls the heating block, manages the samples, does automatic calculations, and depyrogenates the glass tubes.
2. Is PyroGel 21 CFR Part 11 compliant?
   Sample Tracking is a newly developed application capable of registering, storing and managing the data related to samples. Sample Tracking provides the samples for the PyroGel and also receives the approved measurement results from PyroGel.
3. What is PyroTherm?
   PyroTherm is the computer controlled heating block for gel-clot testing & depyrogenation with multitube ( 4 x 12 or 8 x 12) capability. Temperature range is from room temperature + 4°C to 250°C with programmable cooling & timing controls.
4. What are the main advantages of the PyroTherm compared to the water bath?
   
   • software controlled metal thermostat ensures more stable temperature than the water bath
   • vibration free solid metal
   • no water drops when taking out vials
   • capable of depyrogenation - real-time temperature monitoring
5. Can I use PyroTherm for other applications?
   Yes! Soon you will be able to integrate other application programs, such as PyroTest and PyroPrep to PyroTherm.
6. What is a EQU & EQUAL?
   EQU is an Application Integration System. It is a natural language SQL, modeling, & visualization development system, that can be connected through standard protocols to databases. EQU ActiveX with application packages is called EQUAL. EQUAL can be embedded into other applications.
7. How does EQUAL work?
   EQUAL models are natural language SQL sentences. Each model contains one ore more sentences with embedded parameters. The parameters may be defined by the user to obtain results in the form of tables & graphs about the model. EQUAL within application environment can generate thousands of decision models.
8. What kind of database does PyroGel use?
   PyroGel uses MSSQL 7.0 database for fast and secure access. Database access can be configured during the installation/reinstallation procedure.
9. Does PyroGel support documentation of the reagents, supplies and equipment used during a measurement?
   Yes. All of the information – including unique IDs – are stored in the SQL database and can be used in SQC modeling & vendor qualification.
10. Is PyroGel validated?
    Yes. You will receive as part of DQ: Software Validation Plan, Software Validation Summary, and 21 CFR Part 11 Validation Summary.
11. How does PyroGel register the temperature?
    PyroGel is capable of simultaneously registering data from more than one sensor, thus temperature distribution can be measured and stored in the database.
12. What kind of support will I receive after purchase?
    PyroGel package includes extensive documentation, including:
    1. Installation Guide
    2. User Manuals - PyroGel, Sample Tracking, User Manager, & EQUAL
    3. Getting started CD - PyroGel, Sample Tracking, User Manager, & EQUAL
    4. DQ-IQ-OQ-PQ
    5. 24/7 Web-training
    6. 24/7 Web-Technical support
13. What kinds of gel-clot methods are supported in PyroGel?
    All methods approved by the ICH are supported, including: semi-quantitative, limit, inhibition-enhancement and the LAL reagent sensitivity methods.
14. Why should I buy PyroGel?
    
    • PyroGel is the ONLY program on the market, which supports gel-clot testing
      
    • PyroGel offers 21 CFR part 11 compliant solution for your calculation & documentation
    • PyroGel provides full documentation of the equipment & supplies used during testing, and supports vendor qualification
      
    • Multipoint temperature monitoring improves reliability of your results and reduces OOS
    • In situ depyrogenation of the test tubes improves economy & reduces OOS
    • Correlation of data between gel-clot testing & kinetic testing can be done automatically