增强功能可满足您缩短测定运行时间，简化数据输入，减少用户变化和增强管理控制的需求。添加用户管理功能可使系统符合 21 CFR Part 11 标准。
|Endosafe® nexgen-PTS™ 仪器
Product Code Endosafe® nexgen-PTS™ instrument
USB cable adapter
FDA-Licensed LAL cartridge Technology
Reduce Retest Rates. Decrease Variability in Your Endoxin Testing.
There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and while conventional kinetic testing is a tried and trusted method, advances in science have allowed for improvement in how it’s utilized.
The Endosafe® cartridge technology is our innovative response to our customers’ need for higher sensitivity and faster quantitative LAL testing results. Designed to optimize and refine our use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional endotoxin testing methods while reducing time-consuming preparation and technician variability.
Each cartridge contains precise amounts of our FDA-licensed LAL reagent, chromogenic substrate, and controls needed to obtain rapid, accurate results. The cartridges automatically perform a duplicate sample and positive product control, thereby satisfying the harmonized BET chapters USP<85> or EP<2.6.14> for LAL testing.
Each FDA-licensed LAL cartridge is manufactured according to rigid quality control procedures to ensure test accuracy and product stability and is compliant with existing global harmonized regulatory guidelines.
- The User Management function allows for controlling user access and authority of how data is generated and stored making the nexgen-PTS 21 CFR Part 11 compliant ready.
- Results are displayed on the LCD screen and can be exported via Wi-Fi or Ethernet for printing and analysis in LIMS or Charles River Cortex™.
- Searchable audit trail, with every action recorded to ensure data integrity. Add Charles River Cortex for an integrated solution to securely consolidate, query, and analyze all real-time endotoxin data for necessary internal QA and FDA trending reports.
ENDOSAFE® NEXGEN-PTS™ TECHNICAL RESOURCES
The Endosafe® nexgen-PTS™ endotoxin testing instrument utilizes disposable cartridges for accurate, convenient, and real-time endotoxin detection, glucan concentration determination, and Gram identification.
A Pfizer Case Study: Increasing Operational Efficiencies with the Endosafe® Systems
In this webinar, Jeffrey Weber from Pfizer discusses options for endotoxin and compendial testing of pharmaceutical products, with a specific emphasis on the Endosafe® endotoxin testing platforms.
View the Replay
Frequently Asked Questions (FAQs) About Endosafe® nexgen-PTS
Is the Endosafe® nexgen-PTS™ 21 CFR Part 11 compliant?
Yes, the Endosafe® nexgen-PTS™ is 21 CFR Part 11 compliant-ready. It is up to the end user to ensure compliance.
Is there another instrument that can use Endosafe® cartridges besides the Endosafe® nexgen-PTS™?
Yes, there are two other Charles River Endosafe® endotoxin testing instruments that can be used with the Endosafe® LAL cartridge technology:
Only Charles River Endosafe® instruments use cartridge technology. No other brand of endotoxin testing instruments is equipped to use cartridge technology.
When would I select an Endosafe® nexgen-PTS™ instead of an Endosafe® nexgen-MCS™ for my organization’s endotoxin testing needs?
Your organization should select Endosafe® nexgen-MCS™ over Endosafe® nexgen-PTS™ if it tests more than 10 product samples per shift.
How is sensitivity determined for the LAL cartridges?
Charles River supplies LAL cartridges with different sensitivities as the level of endotoxin that is allowed in specific products vary. Your choice of cartridge sensitivity will depend on the type of sample being tested, the endotoxin limit, and level of interference (how much dilution is required). The Charles River Technical Support Team is here to help you choose the correct cartridge sensitivity. Please reach out with any questions you have to [email protected].