Leading the Way in Cleanroom Regulatory Compliance

In today’s highly regulated industries such as pharmaceuticals, biotech and academia, maintaining cleanroom environments that adhere to federal, state, and industry standards is of paramount importance. As a trusted expert in this field, we support companies seeking to meet and exceed cleanroom compliance requirements.

design

Design and Construction

Starting with the design phase, Precision Biotech Solutions provides end-to-end solutions for cleanroom construction. Cleanrooms built to ISO 14644 standards and other regulations ensure precision.

Compliance

Validation and Certification

We conduct thorough validation and certification procedures to confirm that cleanrooms meet the required standards. Their rigorous testing and documentation processes guarantee compliance.

Maintenance

Maintenance and Cleaning

Precision Biotech Solutions offers ongoing support through maintenance services and cleaning solutions. In addition to maintaining cleanroom conditions over time, this prevents compliance deviations.

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Compliance Audits

As part of the compliance audit process, PBS can identify potential areas for improvement and assist in rectifying any discrepancies. Clients are therefore well prepared for regulatory inspections.

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Training and Education

A key component of maintaining cleanroom compliance is knowledge and training. Training programs are offered to educate employees on best practices and regulations.

Company Challenges:

When it comes to cleanroom facilities, the healthcare and pharmaceutical industries are subject to stringent regulations and standards.

Product quality can be compromised by non-compliance with USP 797 and 800 guidelines.

Cleaning, and repair requirements can constantly be a source of frustration and expense. Maintaining these facilities can be a difficult task without the right expertise, leading to wasted resources, downtime, and regulatory concerns.

Our Solution:

Compliant cleanroom solutions are our specialty. Cleanroom compliance, construction, maintenance, and cleaning are all handled by our team of experts.

Our comprehensive approach ensures your facility is always in top condition with state-of-the-art cleanrooms. Trust us to help you achieve and maintain the highest industry standards.

✦ Benefits and Features:  ✦

Why Choose Precision Biotech Solutions?

Regulatory Compliance: Ensure adherence to industry standards and regulations.

Efficient Construction:

Swift cleanroom setup to minimize construction costs and start operations sooner.

Cutting-Edge Design:

State-of-the-art cleanroom designs that provide optimal environmental control and product quality

Scheduled Maintenance:

Proactive upkeep for reliable cleanroom performance and equipment longevity.

Decontamination Expertise:

Thorough cleansing by specialists to safeguard products and enhance safety.

Customized Solutions:

Tailored services that match your unique requirements, ensuring maximum efficiency and compliance for your cleanrooms.

Cost-Efficient Solutions:

Solutions for high quality, cost-effective cleanrooms that do not compromise compliance or quality.

Comprehensive Cleaning:

In-depth cleanliness protocols for all surfaces and equipment, leaving no room for contamination.

Emergency Repairs:

24/7 support to address unexpected cleanroom issues, minimizing downtime and losses.

Cleanroom regulatory compliance is Precision Biotech Solutions’ expertise, which extends beyond construction to validation, maintenance, and ongoing support. With our help, our clients are able to maintain product quality, safety, and regulatory compliance, contributing to their success.
✦ Testimonials  ✦

What Clients Say About Us?

Your team has brought such great value to our company, we are all truly grateful for all your hard work! You have an excellent company and will definitely recommend to other members in the industry.
Harin K.
Pharmacy Operations Manager
I wanted to reach out and give some big kudos to Leif and Mario from your company as they did a tremendous job. Our Pharmacy unfortunately flooded from the winter storm back in February and we were absolutely devastated. We were able to reach out to your company and got in touch with Leif. He walked us through the build back and kept communication lines open and gave us periodic updates throughout the process. We had some obstacles to get through, but we all worked together to fix them, and the finished product is perfect.
Mark B.
Director of Pharmacy Operator
✦ WHat we offer ✦

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