Demo Slide

Why

we do it better

Our professional hand picked team come from a broad spectrum of backgrounds in biotechnology, engineering, and information sciences. When we take on a project, our whole team gets involved, and we don't take on multiple projects simultaneously.

beepix is your one source for design, engineering, and validation Support

Facilities Design

Standards-based environmental design upheld by years of experience designing, testing, and remediating of the most stringent aseptic facilities.

    • Aseptic Processing Area
    • Restricted Access Barrier System (RABS)
    • Isolator Technologies (+/- Pressure)
    • Line Qualification & Media Runs
    • Establishing Boundaries & Worst-Case
    • Training & Assessment

Component Sterilization

We provide expertise to help our clients establish appropriate sterilization process, from component wrapping/packaging material, to load configuration and hold-times.

    • Dry Heat Sterilization
    • Steam Sterilization
    • Irradiation (Gamma & EBeam) Sterilization
    • Hydrogen Peroxide Decontamination
    • Pulsed UV
    • Sterile Hold time

Process Automation

Strategy recommendations to meet clients business objectives. The baseline approach ensures the security of the production data while maintaining the ability to share information across a wider network.

    • Process Control Network
    • manufacturing Execution System (MES)
    • Enterprise Manufacturing Intelligence
    • Challenging Process Data & Information Security
    • Recipe Management
    • Alarm Handling

Environmental Certification

Beepix Environmental Qualification & Certification programs verify facility performance to appropriate international standards and client requirements.

    • AHU Specifications & Commissioning
    • Air Balancing & Recovery
    • Air Velocity & Filter Certification
    • Airflow Visualization Studies
    • Environmental Qualification
    • Routine Monitoring Sites & Rational

Equipment Qualification

Establish and challenge critical process parameters with respect to contamination control, fill volume, headspace lyophilization, sealing and the client's business needs.

    • Multi-Product & Multi-Purpose Facilities
    • Cleaning & Sterilization of Product contact Parts
    • In-line Washing & Depyrogenation
    • Stopper Processors / Siliconization
    • Lyophilization, CIP & SIP
    • Capping & Crimping
    • Seal Force & Ingress Studies
    • Inspections Systems

Quality Systems

Establish the infrastructure to maintain policies, procedures, and guidelines that are required to demonstrate our client's adequate and effective quality systems approach.

    • Document Templates
    • Qualification Documents
    • Training Documents
    • Project Plans & References
    • Version Control & Approval Process
    • Traceability & Review
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Proven life cycle
A highly disciplined approach that promotes meticulous design, development, and verification necessary to supports flexibility and agility throughout the build process

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CONTACT

beepix llc
115 River Road, Suite 201
Edgewater, NJ 07020
T (201) 222 2720
Email: contact@beepix.com
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Tok Han
Pfizer Bioprocess

I truly thank Beepix’s help for achieving the manufacturing of DP batch milestone.  We could not have done it without your help. This project had more than a fair share of challenges and obstacles, but your non-negotiable determination for success and relentless hard work helped us to achieve this accomplishment.

Gary Schmidt
Wyeth Vaccines

Your team’s experience, dedication, attention to detail, effective communication and foresight were the key to qualifying our vial-line. Please extend my gratitude to all of them.

Shachi Sharma
Boehringer Ingelheim

I just want to let you know how pleased I am with the performance of Beepix. Your team has truly taken a lead role, working well with our engineering, operations, and maintenance to schedule and execute our validation effort.

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