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Q: What are the benefits of microfluidic automation?
Microfluidic automation is the simplest form of automation available to the market today. It simplifies endotoxin testing in a platform that is extremely easy to set up, use, and maintain. With microfluidic automation comes high throughput, quick assay setup, minimal hands-on time, and easy training. The Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform uses a standard benchtop analyzer in terms of footprint, size, and basic functionality that is paired with the Eclipse microplate to automate assay setup. By leveraging microfluidic liquid handling and the platform’s embedded endotoxin standards and positive product controls (PPCs), quality control analysts can easily and quickly begin a fully compliant endotoxin assay in 9 minutes and in as few as 27 pipetting steps, with up to 21 samples.
Another benefit of microfluidic automation relates to pipetting. Pipetting is one of the largest contributors to errors and retests in the endotoxin market, so by reducing the pipetting steps to less than 30, the Eclipse platform mitigates risks and opportunities for errors that lead to costly retests. In addition, the microfluidic liquid handling precisely measures all liquids for the end user. This means that the precision typically required during the physical action of pipetting is eliminated through the precise design of the Eclipse microfluidic microplate. Microfluidic automation enables labs to achieve the high throughput and easy assay setup they want, without having to be concerned about footprint, complex validations, or compliance.
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Q: What components make up the Eclipse BET platform?
The Eclipse BET platform consists of three components: (1) An analyzer that is an incubating spectrophotometer, just like other instruments used for kinetic endotoxin testing; (2) A microplate that automates the assay through microfluidic liquid handling, pre-deposited endotoxin standards, and pre-deposited PPCs; (3) Enterprise software that has convenient protocols and libraries, fully customizable permissions, and of course, full compliance with 21 CFR Part 11 and data integrity guidelines.
Q: How does microfluidic automation work?
Within the Eclipse microplate, microfluidic liquid handling facilitates accurate and rapid dispersion of reagents and samples with drastically reduced volumes of sample and LAL. This is achieved using microfluidic channels, metering chambers, and centrifugal force as the microplate spins to control and automate all liquid measurement, flow, and mixing in preparation for analysis. Preloaded standards and PPCs are used to automate standard curves and PPC spikes. In addition, the closed microfluidic system prevents environmental contamination and precisely delivers a 1:1 sample to lysate ratio. With microfluidic automation, compendial endotoxin assays are performed effortlessly and with fewer retests.
Q: Are standard curves automated?
Traditionally, for an endotoxin assay to remain compliant, the end user must construct at least a three-point standard curve in duplicate from a stock vial of standardized endotoxin; must have duplicate negative controls; and must run each sample in duplicate with a PPC, also in duplicate. However, because Eclipse automates these steps with preloaded endotoxin standards spanning up to a five-point standard curve and preloaded PPCs, all the end user has to do is load Water for BET and samples onto the plate with no additional prep work. The result is the ability to set up the assay in 9 minutes, compared to upwards of 60 minutes that other platforms require. With the Eclipse platform, lab technicians are thrilled with how simple and quick assay setup is!
Q: Is it compliant?
Yes. The Eclipse platform uses commercially available, FDA licensed LAL and meets all requirements of the harmonized global pharmacopoeia, USP <85>, EP 2.6.14 and JP 4.01. Regarding data management and integrity, Eclipse software was designed with ALCOA+ principles at the forefront to provide a highly customizable enterprise solution with 21 CFR Part 11 and data integrity compliance features. To summarize, the Eclipse platform includes:
- Minimum three-point standard curve in duplicate using standardized endotoxin
- Samples and PPCs in duplicate
- Negative controls in duplicate
- Analyst and lysate lot qualification in triplicate
- Use of FDA licensed LAL
- Compliance with 21 CFR Part 11 and data integrity guidelines
Q: How much LAL reagent is needed?
With just 1 mL LAL reagent, 21 samples can be run on the Eclipse platform. By decreasing horseshoe crab (HSC) lysate use by up to 90%, the Eclipse reduces the demand on this valuable natural resource and delivers a fully compliant BET assay that the global HSC population can sustain.
Q: Is training difficult?
Since so much of the difficult assay setup is eliminated with the Eclipse, training and analyst certification are extremely straightforward. Once the system is fully validated, an analyst can be trained and certified within one day using the template in the software. This function conveniently allows a lab manager to keep track of who is qualified, unqualified, or due for requalification.
Q: Are there unique considerations around method transfer and validation?
Regardless of the current state of endotoxin testing, transitioning to an automated and efficient platform is extremely straightforward with the Eclipse platform – method transfer, validation, and all. SUEZ supports customers with expert guidance for implementation of the Eclipse, including method suitability testing, product validation, and system validation. These necessary steps can take place on site or in SUEZ’s lab in Boulder, Colorado.
In addition, the Eclipse platform inherently simplifies training programs, analyst and lysate qualifications, system validation, and product validation. A full IQ/OQ/PQ document is available, as are services provided by SUEZ to further simplify the implementation of this innovative endotoxin solution.
Q: How are data review and sign off handled with Eclipse?
In today’s environment, it is imperative that the data review process allows for security and efficiency. Quality control labs want to readily review and sign off on data and batch release information – and always in a secure manner – in order to release product or in-process materials to continue their manufacturing process. Therefore, an enterprise software solution like the Eclipse that offers secure access from any location is extremely valuable to life science businesses with multiple sites or remote workers.
The Eclipse software has helpful functionality for data review, including the ability to set permissions for each user. If a reviewer needs to differentiate between final product or in-process and raw materials, or perhaps water testing, they’re able to do that within the software. Reports can also be viewed for specific samples individually if necessary. All reports are securely tracked within system and assay-specific audit trails per compliance requirements.
As an enterprise solution, the Eclipse software allows for simple, remote access for data review and electronic signature that makes it convenient and efficient for the quality control lab to use. From the analyst to the quality manager and quality assurance professionals, all software users benefit from the secure, flexible options for reviewing and releasing their samples.
Author Biography
David Wadsworth is the Global Product Manager, Bio-Detection at SUEZ – Water Technologies & Solutions, focusing on next-generation endotoxin detection. Dave has a Bachelor of Science degree in Biology from Wheaton College Massachusetts and has over 14 years of experience in the endotoxin industry. His first introduction to endotoxin detection was as a seasonal employee responsible forcollecting and processing amebocytes for a LAL manufacturer, and he’s been enthusiastic about bacterial endotoxins testing ever since!