Corporate Information

Quantus, Inc.

3 Valley Square

Suite 120

Blue Bell, PA 19422

 

MAIN: (866) 876-6537

FAX: (480) 247-4927

info@goquantus.com

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Our Services

Remit CUSTOMER Check Payments To:

QUANTUS, INC (#65043)

PO Box 4120

Portland, OR 97208

Mailing Addresses

Send SUPPLIER Bills To:

QUANTUS, INC (#23031)

PO Box 37635

Philadelphia, PA 19101-0635

Qualification and Validation Services

 

Our deliverables provide you with properly documented evidence of your process meeting its acceptance criteria

 

Reports are provided within 2 Weeks upon completion of testing

We work closely with our customers in Life Sciences industry to establish well written and properly documented evidence of the completion of qualification and validation protocols, meeting the rigorous standards of the DEA, EMA, and FDA.
 
Our validation professionals provide Facilities & Utilities, Equipment & Instrument Qualification, Process Validation, and Project Management Services.

Our documentation is audit tested and proven to provide our customers with "established evidence that provides a high degree of assurance that their process consistently produces product which meets pre-determined specifications and quality attributes"

Validation Services

Facilites and Utilities Validation

Quantus employs full-time salaried microbiologists and validation specialists that have been trained  to challenge Regulated Cleanrooms with microbial sampling methodolgies, developed with our customers input, to successfully validate the GMP environemnt and provide documented evindence in accordance to current industry standards.

 

Our Team works closely with each of our customers to develop strategic and specific protocols desinged to challenge Faciltiies and Utlities in accordance to current regulations and corporate guidelines.

  • HVAC

  • Control & Monitoring Systems (BAS / BMS / EMS )

  • Temperature & Humidity

  • Differential Pressure

  • Room Classification – Microbial

  • Particle Counts

  • Back Up Generators

  • Clean Steam Systems

  • Compressed Gas Systems

  • Vacuum Systems

  • Waste Systems

  • Water Systems (RO/DI/WFI)

Process Validation

Our validation service team travels the US nation-wide and is capable of supporting small to large-scale process validation projects. We deploy microbiologists and validation specialist to your facility and conduct validation services on many processess. We have experience in PROCESSING THOUSANDS OF SAMPLES, tracking the analysis, and provide proper documentation, providing our customers with evidence that their process is capable of meeting its end-point accurately and repeatedly. 

  • Aseptic Technique

  • Batch Transfers

  • Bin & Tote Washers

  • Bioreactors & Fermentors

  • Cleaning Validation

  • Depyrogenation

  • Filling Machines

  • Glass Washers

  • Gowning Validation

  • Heat & Impulse Sealers

  • Label Validation

  • Labelers, Counter, and Inspection Machines

  • Packaging Machines

  • Printers

  • Shipping Validation

  • Tablet Press

Autoclave Sterilizer Cycle Development & Validation

We assist our customer with medium to long-term cycle development and validation studies to determine the most effective and efficient means in which to sterilize their goods. We help you determine overkill validation cycles appropriate for each product load pattern. Our validation studies are geared towards optimizing your time to sterilize and validate that your validation process used will render a product free of viable organisms. 

Our validation team provides easy to follow validation protocols and final reports which summarize the results in a manner that can be quickly presented to auditors confirming your Autoclave Validation results. Your final document will provide you with evidence that your validation cycle is reliable, repeatable, and is able to successfully sterilize worst-case "Max" load condition.

Equipment Qualification & Temperature Mapping Services

 

We provide validation services and documentation that demonstrates our customers have established evidence that provides a high degree of assurance that their equipment consistently produces results MEETING PRE-DETERMINED SPECIFICATIONS AND QUALITY ATTRIBUTES.

 

Our validation specialists use the best in quality industry-standard validation equipment, to provide you with reliable and repeatable results on every temperature mapping validation project. We have a large array of validation equipment allowing us to provide our customers with a large variety of options when choosing how many data-points and parameters they want to include in their temperature mapping validation study.

 

  • Cryogenic Storage Units

  • Freezers

  • Incubators

  • Lyophilizers

  • Mobile and Temporary Storage

  • Ovens (Standard, High-Temp, Vacuum)

 

  • Refrigerators

  • Stability Chambers

  • Tubing & Bio Welders

  • Ultra-Low Freezers

  • Walk-In Storage Units

  • Warehouses

Cold Chain Temperature Mapping

In addition to our warehouse, walk-in. freezer, and refrigerator temperature mapping validation services, we also support the temperature mapping of the entire logistical path that your product travels. We will provide documented evidence that your process can routinely provide an unbreakable COLD CHAIN using our temperature mapping services with both off-the-shelf and customizable protocols.

  • Distribution and Warehouse Centers

  • Transport Vehicles

  • Cold Storage

  • Airline & Shipping Containers

Analytical Instrument Qualification

Our regulated customers require Installation Qualification (IQ) Services in order to obtain documented evidence that their equipment has been Installed in accordance with their process specification. Additionally, our Operational Qualification (OQ) Services fulfill customer requirements to document the installed equipment operates within predetermined limits when used in accordance with their SOPs.

  • AKTA Pilot FPLC

  • AKTA Process FPLC

  • AKTA Purifier FPLC

  • Analytical Balances

  • Micro Plate Readers
  • Micro Plate Washers

  • Nano Drop

  • Osmometers

  • Thermocyclers

  • UV-VIS Spectrophotometers

Dissolution Bath Calibration Mechanical Qualification

Our Dissolution Bath services support your routine calibration and mechanical qualifications services requirements. Quantus validation service personnel have been trained on providing Dissolution Equipment Services, including: Calibration, Installation Qualification (IQ), Operation Qualification (OQ), and Mechanical Qualification (MQ) to meet FDA 21 CFR 211.160 and ASTM E2503 Guidance.

Project Management

Our validation team is available for short and long-term projects to support facilty conversions, improvements, and/or gap analysis with remediation scope developement. We can provide multiple project managers or assign a point project manager and

COST CONTROL THE PROJECT by providing specialist that will report to our project leader/manger.

  • Track QA Approvals

  • Manage Logistics for Personnel & Equipment Availability/Usage

  • Execute Approved Protocols

  • Summarize & Report Data

  • Follow Up & Ensure Satisfaction

  • Initial Walk-Down Scope Development

  • Project Proposal

  • Defined Timelines for Deliverables

  • Detailed Service Agreements

  • Protocol Development and Approval Routing

  • User Friendly Protocols