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Cleanroom Consulting Services

Consulting” is a broadly used term that often serves as an umbrella of expertise. Acumen’s consulting expertise lies in offering validation services, environmental monitoring plans, and full-service microbiology laboratory tests to facilities similar to yours. We consult on cleanrooms and clean manufacturing facilities like:

Pharmaceuticals | Biotechnology | Medical device manufacturers

... and other healthcare-driven industries that maintain a strict cleanroom environment.

Contact us to learn more

Aside from offering comprehensive consulting services, Acumen also handpicks the best:

Environmental monitoring
Containment
Cleanroom needs and cleanroom design services
Contamination Control
Static control

... and general sterilization providers across the country, serving as a cleanroom solution “boutique” that does topic research to bring you the very best options. We collaborate closely with every manufacturer we partner with because we believe in their solution (of course), and we believe in them. 

At Acumen, we won’t suggest an option to you that we wouldn’t pick for ourselves. That’s why you can trust our cleanroom consultants and the in-house expertise they offer, or the crucial technical information we translate from manufacturers. 

For example, you run into a static control issue. You can join a conference call with an in-house consulting expert at Acumen and a solution expert at Static Control International to find a solution the same day.


Common cleanroom consulting requests Acumen addresses include:

Validation Services

One of your available cleanroom consulting services includes validation services that help you meet the standards of your product and your process, while also fulfilling requirements laid out by regulatory authorities. Specializing in pharmaceutical and medical device operations, Acumen offers the following validation services:

  • Process Equipment Qualifications

  • Cleanroom Qualifications

  • Cleaning Validations

  • Sterilization Methods

  • Analytical Methods

Environmental Monitoring Plans

Having a comprehensive environmental monitoring plan for your facility lays a solid foundation for facility standards and operating procedures. Acumen Technology specializes in creating and revising an environmental monitoring plan to maintain the critical conditions of your facility, helping you meet ISO regulatory requirements, whether you work in:

  • Medical device manufacturing or automotive manufacturing (ISO 8 or 7)

  • Aerospace manufacturing (ISO 6 or 5)

  • Aseptic pharmaceutical manufacturing or semiconductor manufacturing (ISO 5)

  • Nanotech (< ISO 5)

.... or other clean industries.


Full-Service Microbiology Laboratory

From continued years offering cleanroom consulting services for cleanroom environments and critical environments like aseptic pharmaceutical manufacturers, Acumen Technology offers sophisticated laboratory testing through its laboratory partners for:

Regulatory/certification reasons | Regulatory safety | Product yield reasons

Whether you need cleanroom testing for an existing facility or are planning for validation prior to cleanroom construction, you can trust that Acumen provides detailed and consistent information as a part of our cleanroom consulting services. When we work together, we find better solutions. And with better solutions in place, we deliver an end-product everyone involved is proud of. 

And for healthcare-driven industries and biotechnology institutions, these microbiological tests can make or break a product or an entire process. To protect and help maintain the integrity of both, Acumen works closely with its laboratory cleanroom testing partners to provide the following list of abbreviated tests:

  • Biological Indicator Sterility

  • Product Sterility Testing

  • Validation of Bioburden Method

  • Bioburden Determinations

  • USP Chapter <61/62>

  • Antimicrobial Effectiveness

  • Biological Indicator Performance

  • Product Inoculation

  • Total Plate Count

  • Water Testing

  • Filter Integrity

  • Organism ID

  • Antimicrobial Preservative Effectiveness

  • Barrier Metal Testing

  • Surgical Drapes & Gowns

  • Package Testing

  • Particulate Analysis

Whether you need cleanroom testing for an existing facility or are planning for validation prior to cleanroom construction, you can trust that Acumen provides detailed and consistent information as a part of our cleanroom consulting services. When we work together, we find better solutions. And with better solutions in place, we deliver an end-product everyone involved is proud of. 


Contact us to learn more