Instrumentation Validation

CQV VALIDATION SERVICES

  • 503 B cGMP VALIDATION SERVICES

  • ANALYTICAL INSTRUMENT QUALIFICATION

  • AUTOCLAVE VALIDATION

  • COLD CHAIN MAPPING VALIDATION

  • CTU TEMPERATURE MAPPING

  • FACILITIES & UTILITIES CQV 

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Our Onsite Services

CQV Validation Services

Facilities and Utilities Commissioning, Qualification, and Validation (CQV) Services

  • 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)

Quantus employs full-time salaried microbiologists and validation specialists that have been trained  to challenge Regulated Cleanrooms with microbial sampling methodologies, developed with our customers input, to successfully validate the 503B cGMP environments and provide documented evidence in accordance to current industry standards.

 

Our Team works closely with each of our customers to develop strategic and specific protocols designed to challenge Facilities and Utilities in accordance to current regulations and corporate guidelines. learn more

 

Facility Commissioning Qualification Validation
Process and Packing Equipment Validation Service

Process Validation Services

  • 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

Our validation service team travels the US nationwide and is capable of supporting small to large-scale process validation projects. We deploy microbiologists and validation specialists to your facility and conduct validation services on many processes. 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. 

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 the worst-case "Max" load condition.

Autoclave Calidation and Cycle Devlopment Service

Equipment Qualification & Temperature Mapping Services

Bench Top Autoclave Sterilizer Validation Service

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 specification 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

Warehouse Temperature Mapping

Warehouse, distribution center, and walk-in temperature mapping validation services. We support the temperature and humidity parameters throughout your large scale controlled environments. We will provide documented evidence that your large scale controlled storage areas can routinely perform in a uniform manner in both SUMMER and WINTER conditions.
  • Distribution Centers

  • Large Scale Warehouse Storage

  • Walk-in Coolers

  • Other Walk-in Controlled Environments

Warehouse Temperature Mapping Validation Service
Cold Chain Temperature Mapping Validation Service

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.

  • Validated Coolers & Transport Containers

  • 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.

  • Micro Plate Readers

  • Micro Plate Washers

  • Nano Drop

  • Osmometers

  • Thermocyclers

  • TOC Analyzers

  • UV-VIS Spectrophotometers

Analytical Equipment Qualification Service
Dissolution Qualification

Dissolution Bath Calibration and
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 Services

Our validation team is available for short-term and long-term projects to support facility conversions, improvements, gap analysis projects, and remediation services. You will be provided a dedicated project manager that will coordinate onsite and offsite activities with a detailed scope of work and project plan. We can provide and manage multiple personnel with varying levels and breadth of expertise to help avoid scope creep and provide built-in cost controls.

  • Initial Walk-Down Scope Development

  • Project Proposal

  • Defined Timelines for Deliverables

  • Detailed Service Agreements

  • Protocol Development and Approval Routing

  • User Friendly Protocols

  • Track QA Approvals

  • Manage Logistics for Personnel & Equipment Availability/Usage

  • Execute Approved Protocols

  • Summarize & Report Data

  • Follow Up & Ensure Satisfaction

Validation Project Managemen Service

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 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"