Innovative rapid microbial testing for the pharmaceutical industry

We have developed an innovative membrane filtration workflow for microbial testing applications for the pharmaceutical industry. The rapid microbiological method offers faster TTR combined with an easy workflow while providing all advantages of the traditional workflow. This allows faster product release and corrective actions during the full manufacturing process.

Through this questionnaire we would like to validate your overall interest in this workflow and the 2 possible loading solutions.

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Context

Rapid Microbiological Methods have been of interest for the pharmaceutical industry for the last decade with a limited adoption rate due to high manual workload, need for highly skilled personnel, limited performances or difficulties to validate.

Solutions

We have developed an innovative membrane filtration solution for microbial testing (for example for water testing, bioburden, rapid screening) which provide faster results without changing the traditional workflow.

The workflow is very close to the traditional bioburden & pharmaceutical water testing workflow, with shorter TTR:
1. Sample filtration & a touch-free membrane transfer to the media plates
2. Incubation for 24h (bacteria), 48 hours (yeast & mold) or 72/96h for very slow growers (e.g. M.extorquens)
3. The loading can be done in 2 different ways:

Manual loading (solution 1)
Semi-automated loading (solution 2) in case of higher throughput need. It provides a charger to enable the loading of multiple samples which are automatically processed by the reader

4. Automated read-out down to 1CFU. Total handling time 2 min and 5 minutes reading / sample. Compatible with standard identification methods after re-incubation

The method will be validated in compliance with international standards and a service offer to support method implementation and validation by the supplier will be available.

Your advice

Are you interested in a rapid testing workflow for Total Viable Count (TVC)?

Not at all interested

Not very interested

Neutral

Somewhat interested

Very interested

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How interested are you in each of the following loading solutions?

0 star = Not interested at all / 5 stars = Highly interested

1Solution 1: manual loading

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2Solution 2: semi-automated loading

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For which intended purposes would you use those solutions?

You can select up to 4 items

Rapid Screening / troobleshooting

Alternative method to water testing and bioburden testing

Alternative method to Sterility testing

Other (please specify in the comment section)

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For which matrices would you use those solutions?

You can select up to 5 items

Water testing

In-process samples

Raw materials

Final products

Other (please specify in the comment section)

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For the matrices you selected above, indicate how many samples it would represent per day.

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Would you be willing to buy solution 1 (manual) as it is described?

Please briefly explain your choice in the comments

Definitely not

Probably not

Probably yes

Definitely yes

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Would you be willing to buy solution 2 (semi-automated) as it is described?

Please briefly explain your choice in the comments

Definitely not

Probably not

Probably yes

Definitely yes

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If you are not positively interested in either of those solutions, what feature(s) would you need?

Please specify if your comment is about solution 1 (manual), solution 2 (semi-automated) or both.

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Which business model would you prefer?

For the rapid solution, only the hardware is required, no consumables are required additionally.

One time hardware price: 150k€

5 years hardware payment: first year 50k + 20k annually for 5 years

Neither

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If you selected "Neither" in the previous question, what price or business model would be acceptable for you?

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Do you think your company could

You can select up to 3 items

Be a customer

Participate in development

Other (please specify in the comment section)

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What is the best way to contact you?

Email address, phone number, Teams meeting, etc.

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