Hello Mike,
Welcome to Bacterial Endotoxin Testing (BET).
I think this question is a lot for this forum but I will give it a shot. I would suggest contacting one or all of the of the manufactures. Obviously, they are going to be eager to help you.
Beyond the reagents you will need to purchase a reader and software. Each manufacture has their own proprietary software to interface with the reader and interpret results. It is possible to run the test without proprietary software and readers but it would be very difficult to start that way.
Some of the consumables are pipette tips, various glass tubes, BET grade water and possibly 96 well plates. Each manufacturer sells what you need to run their test. I highly suggest you use what they sell, especially when you are starting up a lab. I have seen, over the years, consumables cause great amounts of pain. Once you choose a manufacturer purchase everything that touches the test from them. They will be more expensive and you will be tempted to purchase something cheaper somewhere else but don't do it until you are an experienced user. You will regret it. Everything, every little thing, that touches the test affects the test. Staying with the manufacturer's consumables ensures that none of them will negatively impact the assay.
Learning to run the assay is not difficult. The manufacturers are typically more than happy to provide all the training you will need to get started using their products. Some will be happy to train you at your site and others may invite you to their site to be trained. The assay can be mastered by most lab techs with good pipetting skills in fairly short order.
There are some costs involved with keeping equipment maintained. Pipettes need to be kept certified and calibrated. The reader will need to be certified/calibrated at least annually.
I know that at least two of the manufactures will be happy to assist you with setup and validation of your testing system at your facility.
At least one of the manufactures offers a testing service where you could send samples for testing. If you are only running a few samples per month you might want to consider this. If you are not running enough tests it may be difficult to keep a technicians skills sharp.
If you have further questions please feel free to contact me directly.
Best Regards,
Sean A. Hauber
Associates of Cape Cod
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Mobile: 858-356-7600
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Michael Barton
Sent: Thursday, February 16, 2023 7:15 AM
To: [log in to unmask]
Subject: [PMFLIST] Endotoxin testing <85>
Hi All,
firstly i have no experience with endotoxin testing as i am used to non-sterile manufacture and testing. However i have been asked to look into the possibility of setting up endotoxin testing. we are looking at this test for medical device component items initially.
Can anyone please share what amount of effort, equipment, consumables, validation, running costs, specific test environment and difficulty with knowledge/expertise for issues and failures i would expect to deal with and need to overcome. Anything else you think would be good to highlight then please do.
Would it only be cost effective and appropriate to maintain skills, calibrated equipment and consumables etc if there was a constant daily throughput of a specific number of batches to test.
i will be looking to research this topic but as a starter im hoping that some of you could share your experience with me.
thank you
Mike
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