Modern Microbial Methods Survey

Introduction

Technologies that allow faster detection of microbial contamination continue to offer potential in improving the monitoring of materials and processes, as well as enabling the accelerated release of materials while ensuring the quality and safety of our finished products. These methods are referred to as Rapid, Alternative, or Modern Microbial Methods.

These methods are considered non-traditional and are able to quantify and/or detect the presence of microbes, or their by-products in a time to result which is significantly less than traditional methods. These approaches can include direct enumeration, accelerated/metabolism based assays, identification of microbes from a sample of the production batch, or directly measured from a material or product stream.

The purpose of this survey is to collect data to understand where and how these technologies are currently being evaluated and used across a range of industries (e.g. consumer goods, food, medical devices, sterile pharmaceuticals and cell therapies). The results will be shared broadly via publications and presentations which will support a better understanding of what is needed for widespread adoption in all industries.

Question Title

* 1. What is your business sector (select all that apply)?

Non-sterile manufacturing (pharmaceuticals, OTC, consumer goods, etc.)

Sterile pharmaceutical manufacturing (small molecule, ophthalmic, etc.)

Sterile biopharmaceutical manufacturing

Advanced Therapeutic Medicinal Products (ATMPs)

Medical device/ Combination product

Food

Personal care/Cosmetics

Other (please specify)

Question Title

* 2. What is your primary role?

Research and Development

Quality Control

Quality Assurance

Microbiology Quality and/or Sterility Assurance

Validation (process, method, equipment)

Manufacturing/Operations

Engineering

Information Technology

Business management

Other (please specify)

Question Title

* 3. How do you view RMM's in your company (select all that apply)?

We widely use rapid methods within our business and look to replace traditional methods.

We use rapid methods selectively within our business for release in combination with traditional methods.

We use rapid methods for monitoring processes and materials but use traditional methods for release.

We are exploring and using rapid methods selectively within our business for process monitoring and release, in combination with traditional methods.

We don’t need RMM’s for our production or product type and are happy with traditional methods.

We are using a third party laboratory or service provider for rapid methods.

Other (please specify)

Question Title

* 4. What is the primary barrier to your organization adopting or using RMMs?

We lack expertise and/or the resources to qualify RMMs.

We are currently using RMM's but lack confidence in the acceptance of data generated relative to tried and tested traditional approaches.

We like the idea of Rapid methods, but will only use them once they are mandated by regulatory agencies.

We perceive the regional or global regulatory hurdle is too high for RMM adoption.

The investment and cost for development is too high and difficult to justify.

Other (please specify)

Question Title

* 5. What is your `time to result` expectation for a Rapid Microbiological Method (Select all that apply)?

	Real time	< 8 hours	Within a shift	24-48 hours
Nonsterile (pharmaceuticals, OTC, consumer goods, etc.)	Nonsterile (pharmaceuticals, OTC, consumer goods, etc.) Real time	Nonsterile (pharmaceuticals, OTC, consumer goods, etc.) < 8 hours	Nonsterile (pharmaceuticals, OTC, consumer goods, etc.) Within a shift	Nonsterile (pharmaceuticals, OTC, consumer goods, etc.) 24-48 hours
Sterile pharmaceuticals (small molecule, ophthalmic, etc.)	Sterile pharmaceuticals (small molecule, ophthalmic, etc.) Real time	Sterile pharmaceuticals (small molecule, ophthalmic, etc.) < 8 hours	Sterile pharmaceuticals (small molecule, ophthalmic, etc.) Within a shift	Sterile pharmaceuticals (small molecule, ophthalmic, etc.) 24-48 hours
Sterile biopharmaceuticals	Sterile biopharmaceuticals Real time	Sterile biopharmaceuticals < 8 hours	Sterile biopharmaceuticals Within a shift	Sterile biopharmaceuticals 24-48 hours
ATMPs	ATMPs Real time	ATMPs < 8 hours	ATMPs Within a shift	ATMPs 24-48 hours
Medical device/combination products	Medical device/combination products Real time	Medical device/combination products < 8 hours	Medical device/combination products Within a shift	Medical device/combination products 24-48 hours
Food	Food Real time	Food < 8 hours	Food Within a shift	Food 24-48 hours
Personal care/Cosmetics	Personal care/Cosmetics Real time	Personal care/Cosmetics < 8 hours	Personal care/Cosmetics Within a shift	Personal care/Cosmetics 24-48 hours

Question Title

* 6. We currently use RMMs for (select all that apply):

Finished product release

In-Process product monitoring

Water system monitoring

Compressed air/gas monitoring

Environmental monitoring

Bioburden testing (raw materials, intermediates, etc.)

Specific and/or objectionable organism testing

Mycoplasma

Other (please specify)

None of the above

Question Title

* 7. Where the RMM is used for finished product release, what is the product category (select all that apply)?

Nonsterile pharmaceuticals (pharmaceuticals, OTC, consumer goods, etc.)

Sterile pharmaceuticals (small molecule, ophthalmic, etc.)

Sterile biopharmaceuticals

ATMPs

Medical device/combination product

Food

Personal care/cosmetics

Other (please specify)

None of the above

Question Title

* 8. Where RMMs are used in relation to a process what is the purpose?

Process monitoring for information only or trending

Process Analytical Technology (PAT) for product release

Confirmation of effective sanitization/disinfection

For support of microbial data deviations and investigations

For validation and qualification

Other (please specify)

None of the above

Question Title

* 9. Do you use RMM for routine monitoring of critical utilities (select all that apply)

Compressed air

Gases (CO2, Nitrogen, etc.)

Pure steam (condensate)

Purified water

Water for Injection (WFI)

Other (please specify)

None of the above

Question Title

* 10. If RMM is used for Environmental Monitoring, which methods (select all that apply)?

Air

Surface

Other (please specify)

None of the above

Question Title

* 11. If RMM is used for raw materials or intermediates, what is the primary use of this data?

Monitoring only (tracking and trending)

As a critical product variable (alert and action levels)

As a specification to be met for product release

Other (please specify)

None of the above

Question Title

* 12. Has your company successfully implemented any RMM?

Yes

Not sure

Question Title

* 13. Does your company have a formal process for evaluating RMM?

Yes

Not sure

Question Title

* 14. If your company has a formal process, which steps are included in the process (select all that apply)?

User Requirement Specification (URS) development

Cross-functional review of existing data (supplier)

Return on Investment (ROI) assessment

Onsite evaluation (prior to purchase)

Single source supplier vulnerability assessment

Regulatory strategy

Consumable supply chain logistics (local and global availability)

Other (please specify)

Question Title

* 15. Who are the primary stakeholders that are involved in this process?

Research and Development

Quality Control

Quality Assurance

Regulatory Affairs

Microbiology Quality and/or Sterility Assurance

Validation

Manufacturing/Operations

Engineering

Information Technology

Business management

Other (please specify)

None of the above

Question Title

* 16. Did the implemented RMM require regulatory approval?

Yes

Not sure

Question Title

* 17. Has your company worked with any regulatory team supporting RMM (FDA Emerging Technology Team, MHRA Innovation Panel, etc.)?

Yes

Not sure

Question Title

* 18. Do you believe that regulatory agencies are providing enough guidance on how to validate RMM that do not use the Colony Forming Unit (CFU)?

Yes

Not sure

Question Title

* 19. If no, what do you think is needed (check all that apply)?

Specific regulations requiring the use

Revision of specifications accommodating new units of measure

Guidance on risk management of these new units of measure

More peer reviewed publications on validation and use

Other (please specify)

None of the above

Question Title

* 20. What RMM technologies has your company evaluated (select all that apply)?

Laser induced fluorescence in flow (cytometry, etc.)

Laser induced fluorescence off-line (microscopy, etc.)

ATP Bioluminscence

Metabolite based (pH, CO2, etc.)

PCR

Other

None of the above

Question Title

* 21. What are the biggest challenges with commercially available products (please rank these in order - 1 highest priority, 6 lowest priority)?

Integration into existing facility systems

N/A

LIMS capability

N/A

Single sourced consumables or reagents

N/A

Validation or service support

N/A

Data acquisition and interpretation

N/A

Cost

N/A

Question Title

* 22. What are the biggest hurdles your company has found in adopting RMMs?

The lab-based validation data does not directly translate to the process- with additional work required to understand the data beyond standard suitability testing.

Technology is limited to tracking and trending, with additional testing required for release.

Existing technology is not suited to measuring microbes in the process stream.

Perceived regulatory requirements

Other (please specify)

Question Title

* 23. Is your company still using RMM (Please specify the technology and purpose)?

Yes

Not sure

Question Title

* 24. If your company stopped using RMM, what was the reason (select all that apply)?

Data was too sensitive and difficult to explain.

The cost of the method was higher than traditional approaches.

The technology was no longer supported (company went out of business, stopped supporting the method)

We are still using RMM.

Other (please specify)

Question Title

* 25. When evaluating RMM, do you prefer (select all that apply)?

Rent the new technology for internal evaluation prior to purchase decision.

Rent the RMM technology and partner with the supplier in order to customize prior to purchase.

Buy the RMM relying on supplier data and develop internally.

Other (please specify)

Question Title

* 26. Where do you see that RMM's would be of greatest value for your company?

New products only

New and existing products

For investigation, validation or other applications besides routine monitoring or testing

All of the above

None

Other (please specify)

Question Title

* 27. In the past 2 years, have you seen any new RMM that interests you (if yes, please specify)?

Question Title

* 28. What would be the most attractive feature allowing you to adopt an RMM (choose 3)?

Automated/ease of sampling

Faster results

Accuracy (reduced false positive and negative results)

Easy data analysis

Equivalency to current method

Increased sensitivity

Detection of live versus dead cells

Non-destructive to sample

Ability to ID

Other (please specify)

Question Title

* 29. What do you believe to be the top business challenges in adopting RMM (Check up to 3)?

Overall cost (evaluation, validation, implementation, routine, etc.)

Internal regulatory acceptance

External regulatory acceptance

Acceptance among other teams (IT, manufacturing, etc.)

Comparability to existing methods

Adequate facilities/resources/utilities

Inflexibility of systems to accept new methods/technologies

Other (please specify)

Question Title

* 30. How do you perceive the overall cost of implementing a RMM (select all that apply)?

It is difficult to calculate the ROI.

Equipment costs are too high.

Justifying the cost is challenging because we do not feel that regulatory agencies are accepting reduced testing.

Consumables are too expensive.

Routine service and/or updates are too expensive.

Other (please specify)

None of the above

Modern Microbial Methods Survey

Introduction

Question Title

* 1. What is your business sector (select all that apply)?

Question Title

* 2. What is your primary role?

Question Title

* 3. How do you view RMM's in your company (select all that apply)?

Question Title

* 4. What is the primary barrier to your organization adopting or using RMMs?

Question Title

* 5. What is your `time to result` expectation for a Rapid Microbiological Method (Select all that apply)?

Question Title

* 6. We currently use RMMs for (select all that apply):

Question Title

* 7. Where the RMM is used for finished product release, what is the product category (select all that apply)?

Question Title

* 8. Where RMMs are used in relation to a process what is the purpose?

Question Title

* 9. Do you use RMM for routine monitoring of critical utilities (select all that apply)

Question Title

* 10. If RMM is used for Environmental Monitoring, which methods (select all that apply)?

Question Title

* 11. If RMM is used for raw materials or intermediates, what is the primary use of this data?

Question Title

* 12. Has your company successfully implemented any RMM?

Question Title

* 13. Does your company have a formal process for evaluating RMM?

Question Title

* 14. If your company has a formal process, which steps are included in the process (select all that apply)?

Question Title

* 15. Who are the primary stakeholders that are involved in this process?

Question Title

* 16. Did the implemented RMM require regulatory approval?

Question Title

* 17. Has your company worked with any regulatory team supporting RMM (FDA Emerging Technology Team, MHRA Innovation Panel, etc.)?

Question Title

* 18. Do you believe that regulatory agencies are providing enough guidance on how to validate RMM that do not use the Colony Forming Unit (CFU)?

Question Title

* 19. If no, what do you think is needed (check all that apply)?

Question Title

* 20. What RMM technologies has your company evaluated (select all that apply)?

Question Title

* 21. What are the biggest challenges with commercially available products (please rank these in order - 1 highest priority, 6 lowest priority)?

Question Title

* 22. What are the biggest hurdles your company has found in adopting RMMs?

Question Title

* 23. Is your company still using RMM (Please specify the technology and purpose)?

Question Title

* 24. If your company stopped using RMM, what was the reason (select all that apply)?

Question Title

* 25. When evaluating RMM, do you prefer (select all that apply)?

Question Title

* 26. Where do you see that RMM's would be of greatest value for your company?

Question Title

* 27. In the past 2 years, have you seen any new RMM that interests you (if yes, please specify)?

Question Title

* 28. What would be the most attractive feature allowing you to adopt an RMM (choose 3)?

Question Title

* 29. What do you believe to be the top business challenges in adopting RMM (Check up to 3)?

Question Title

* 30. How do you perceive the overall cost of implementing a RMM (select all that apply)?

Question Title

* 31. What country is your company located?

Question Title

* 32. If you would like to receive communication about the results and future presentations/publications, please provide your name and email address.