Let's shape the future of rapid sterility testing in the Pharmaceutical Industry!

Your expertise is critical to shaping the future of rapid sterility testing within the pharmaceutical industry. As a valued professional, your input will help identify key barriers, opportunities, and the overall readiness of the industry to adopt innovative rapid sterility testing technologies.

Completing this survey will directly influence industry advancements, regulatory clarity, and practical solutions tailored to your specific challenges.

The survey takes approximately 5-10 minutes, and your responses will remain confidential. Your time is valuable; as a token of appreciation, respondents will receive a detailed summary of insights gathered from industry leaders.

Thank you for contributing your knowledge to drive progress and innovation!

Section A: Participant Background and Segmentation

A1. What is your role and how is your organization classified? (Select all that apply)

Regulatory Affairs (EMA, National Agencies)

QA/QC Director/Manager - Large Pharma (>1000 employees)

QA/QC Director/Manager - Mid-size Pharma (100-1000 employees)

QA/QC Director/Manager - Small Pharma/Biotech (<100 employees)

Microbiology Laboratory Manager

Contract Manufacturing Organization (CMO) Executive

Technology Provider/Vendor

Investor/Venture Capital

Academic Researcher

Other:

A2. Which pharmaceutical development are you involved in? (Select all that apply)

Sterile Injectables

Monoclonal antibodies (mAbs)

Biologics (Vaccines, Recombinant Proteins)

Cell Therapies

Gene Therapies

CAR-T Therapies

Sterile Ophthalmic Preparations

Medical Devices (that require sterility testing)

Other

A3. What is your company's geographical scope? (Select all that apply)

Germany

France

UK

Italy

Spain

Netherlands

Switzerland

Denmark

Sweden

Pan-European operations

Untitled checkboxes field

US

Japan

China

India

Middle-East

Other:

A4. How many years of experience do you personally have in the pharmaceutical market?

A

<5 years

B

5-10 years

C

11-20 years

D

>20 years

Section B: Current Sterility Testing Practices and Pain Points

B1. What is the monthly volume of sterility tests conducted at your company?

A

<100 tests

B

100-500 tests

C

501-1000 tests

D

1001-5000 tests

E

>5000 tests

B2. Rate the severity of these challenges in your current sterility testing workflow:

Scale: 1 = No Problem, 2 = Minor Issue, 3 = Moderate Concern, 4 = Major Problems, 5 = Critical Barrier

B3. For products with shelf-life less than 30 days, how often does the 14-day sterility test create release challenges?

A

Never

B

Rarely (<25% of batches)

C

Sometimes (25-50% of batches)

D

Frequently (51-75% of batches)

E

Always (>75% of batches)

F

Not Applicable (e.g. no short shelf-life products or other reasons)

B4. Estimate the annual cost impact of current sterility testing delays:

A

< 100.000 EUR

B

100.000 - 500.000 EUR

C

500.000 - 1.000.000 EUR

D

1.000.000 - 5.000.000 EUR

E

> 5.000.000 EUR

F

Unable to quantify

Section C: Rapid Sterility Testing Awareness and Adoption

C1. Please rate your familiarity with these rapid sterility testing technologies:

Scale: 1 = Not familiar, 2 = Heard of it, 3 = Understand basics, 4 = Good knowledge, 5 = Expert Level

C2. What is your current implementation status?

A

Currently using rapid sterility testing methods

B

Piloting/validating rapid methods

C

Actively evaluating options

D

Considering for future implementation

E

Not currently considering

F

Decided against implementation

G

Other

C3. How likely is your organization to adopt rapid sterility testing within the next 24 months?

A

Very Unlikely

B

Unlikely

C

Neutral

D

Likely

E

Very Likely

C4. Rate the adoption likelihood for each product category that your organization is involved in:

Scale: 1=Very unlikely, 2=Unlikely, 3=Neutral, 4=Likely, 5=Very likely

Section D: Barriers to Adoption and Implementation Challenges

D1. Your organization might have multiple barriers for adoption of rapid sterility tests. Please rank them from most significant (1) to least significant (9):

1

Validation burden and complexity

1

Regulatory uncertainty / Acceptance concerns

1

High capital investment costs

1

Ongoing consumables costs

1

Lack of skilled personnel

1

Technical complexity

1

Integration with existing workflows

1

Unclear ROI

1

Senior management resistance

D2. Each company must independently validate rapid methods, even with vendor data available. How significant is this barrier?

A

Not Significant

B

Bit of a hassle

C

Neutral

D

A pain

E

Critical Barrier

D3. Rate your agreement with the following regulatory-related statements:

Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree

D4. What information would most help justify investing in rapid sterility testing? (Select top 3)

ROI calculations from peer companies

Total costs of ownership analysis

Validation cost estimates

Regulatory success stories

Productivity improvement data

Risk mitigation quantification

Competitive advantage analysis

Section E. Regulatory Environment and Compliance

E1. Rate your familiarity with recent regulatory developments:

Scale: 1 = Not familiar, 5 = Very familiar

E2. How confident are you that rapid sterility testing methods will gain regulatory acceptance for your product categories?

A

Very low confidence

B

Low confidence

C

Neutral

D

High confidence

E

Very high confidence

E3. If implementing rapid sterility testing, what regulatory approach would you prefer? Select all that apply

Type II variation for existing products

Include in new product applications

Participate in regulatory pilot programs

Wait for clearer guidance

Seek pre-submission meetings

Follow industry precedents

Section F: Market Dynamics and Competitive Analysis

F1. How important is rapid sterility testing for competitive advantage?

F2. Which factors would most accelerate industry adoption? Select your top 3.

Regulatory success stories from major companies

Shared validation consortia

Industry association guidance

Harmonized regulatory standards

Cost reduction through economies of scale

Technology provider support programs

F3. What would most encourage your organization to adopt rapid sterility testing? Select all that apply.

Demonstrated regulatory acceptance

Proven cost benefit

Successful case studies

Vendor validation support

Industry consortium participation

Regulatory incentives

Technology improvements

Competitive pressure

F4. Please rate the importance of these features in a rapid sterility testing solution:

Scale: 1 = Not important, 5 = Critical

	1	2	3	4	5
14-day incubation delays batch release
Impact on production timelines
Quarantine costs and inventory holding
False positive investigations
Manual workflow complexity
Resource burden (labor/materials)
Difficulties in meeting regulatory compliance
Testing complex/turbid formulations
Short shelf-life product constraints
Scalability limitations

	1	2	3	4	5
ATP-bioluminescence
Flow cytometry
Solid-phase cytometry
PCR-based detection
Automated microbial detection
Membrane filtration alternatives
Colorimetric/Fluorescent detection

	1	2	3	4	5
EMA/FDA clearly supports rapid sterility testing
EU GMP Annex 1/21 CFR 210/211 provides sufficient guidance
Validation requirements are clearly defined
Regulatory approval process is predictable
Ph. Eur. 5.1.6./ USP<1223> guidance is adequate

	1	2	3	4	5
EU GMP Annex 1 (Revised 2022)
21 CFR Part 210/211
Ph. Eur. 5.1.6 (Alternative Methods)
USP <1071>
FDA Process Analytical Technology (PAT)
EMA/CHMP guidelines on RMMs

	1	2	3	4	5
Results within 24-48 hours
Automated sample processing
Regulatory pre-approval
Equivalent sensitivity to traditional methods
Ability to identify contaminants
Integration with existing systems
Cost-effective consumables
Minimal training requirements

Let's shape the future of rapid sterility testing in the Pharmaceutical Industry!

Section A: Participant Background and Segmentation

A1. What is your role and how is your organization classified? (Select all that apply)

A2. Which pharmaceutical development are you involved in? (Select all that apply)

A3. What is your company's geographical scope? (Select all that apply)

A4. How many years of experience do you personally have in the pharmaceutical market?

Section B: Current Sterility Testing Practices and Pain Points

B1. What is the monthly volume of sterility tests conducted at your company?

B2. Rate the severity of these challenges in your current sterility testing workflow:

B3. For products with shelf-life less than 30 days, how often does the 14-day sterility test create release challenges?

B4. Estimate the annual cost impact of current sterility testing delays:

Section C: Rapid Sterility Testing Awareness and Adoption

C1. Please rate your familiarity with these rapid sterility testing technologies:

C2. What is your current implementation status?

C3. How likely is your organization to adopt rapid sterility testing within the next 24 months?

C4. Rate the adoption likelihood for each product category that your organization is involved in:

Section D: Barriers to Adoption and Implementation Challenges

D1. Your organization might have multiple barriers for adoption of rapid sterility tests. Please rank them from most significant (1) to least significant (9):

D2. Each company must independently validate rapid methods, even with vendor data available. How significant is this barrier?

D3. Rate your agreement with the following regulatory-related statements:

D4. What information would most help justify investing in rapid sterility testing? (Select top 3)

Section E. Regulatory Environment and Compliance

E1. Rate your familiarity with recent regulatory developments:

E2. How confident are you that rapid sterility testing methods will gain regulatory acceptance for your product categories?

E3. If implementing rapid sterility testing, what regulatory approach would you prefer? Select all that apply

Section F: Market Dynamics and Competitive Analysis

F1. How important is rapid sterility testing for competitive advantage?

F2. Which factors would most accelerate industry adoption? Select your top 3.

F3. What would most encourage your organization to adopt rapid sterility testing? Select all that apply.

F4. Please rate the importance of these features in a rapid sterility testing solution:

G. Open ended insights (You're almost there, I promise.)

In your opinion, what single factor would most accelerate rapid sterility testing adoption globally?

What recommendations would you make to improve rapid sterility testing adoption?

If you have any other comments or insights regarding this topic, please share below:

	1	2	3	4	5
Sterile Injectables
mAbs
Biologics
Cell Therapies
Gene Therapies
Sterile Ophthalmic Preparations
Medical Devices