Perfecting the Science of Service
About Us Quantus, Inc. was founded in 2012 on the basis of building a great company focusing on providing our customers operating in the Life Sciences Industry with a One-Source Solution for onsite Compliance Staffing and Technical Services. Over the years we have recruited the most talented and knowledgeable engineers and technicians in the industry. Our team of professionals built our specialized service platform, which is comprised of the following ON-SITE Services:
Calibration & Preventive Maintenance
Certification
Compliance & Technical Staffing
Environmental Monitoring
Validation
Each of our service product lines is designed to provide our customers with the services they require to improve their processes and products, while meeting their corporate and regulatory requirements. Our service documentation has proven reliable in many customer and regulatory audits. We help your operation sustain FDA / EMA Readiness.
Service Product Platform
01 02
Calibration & Preventive Maintenance Lab, Process, and Specialized Equipment
Certification Service Clean Room, HEPA Filters, Biological Safety Cabinets and Fume Hoods
03 04 05 06
Compliance & Tech Staffing Sustainability and Remediation Support
Environmental Monitoring Routine Weekly & Monthly Monitoring
Qualification & Validation Services Facility, Utility, Process, and Equipment
Quality Assurance Systems ISO9001, Document Management, and Online Customer Portal
go quan t us.c om
Calibration & Preventive Maintenance Services Our Calibration Services Division specializes in delivering on-site NIST Traceable Calibration Services to the Life Sciences Industry throughout the Mid-Atlantic Region of the United States. We also support our projects group with Calibration Services nation-wide.
Laboratory Equipment Calibration Services Our NIST Traceable Lab Equipment Calibration Services are designed to improve the accuracy and reliability of critical equipment used for routine applications and projects. Quantus Technicians and Engineers are trained to provide on-site NIST Traceable Calibration Services and Preventive Maintenance Services in conformance to EMA, FDA, and ISO Regulated Industry Standards. We specialize in the calibration and preventive maintenance of common lab equipment using certified Reference Standards capable of measuring: â—?â—?
Centipose, CO2, Conductivity, Differential Pressure, Dimension, Force, Humidity, Mass, pH, Pressure, Rotation, Speed, Temperature, Time, Torque, and more
Laboratory Equipment Calibration & Preventive Maintenance Capabilities -20 & -80 Freezer
Floor & Top-Loading Scales
Analytical Balance
Heat Block & Hot Plate Stirrers
Bench-Top Autoclave
Hybridizer
Bench-Top Oven
Incubator & Stability Chambers
Bottle Roller & Shaker
Pipettes
Caliper, Depth Gauge, Micrometer, & Rules
Pressure Gauges
Centrifuge
Slide Moat
Chart Recorder & Data Loggers Conductivity & pH Meter Cryo Storage / N2 Tanks Differential Pressure
Refrigerators & Freezers Stopwatch & Timers Temperature & Humidity Sensors Thermometer Water Baths
Manufacturing Process Equipment Calibration Services
Specialized Equipment Calibration Services
We provide NIST Traceable calibration services for manufacturing process systems used on a large variety of applications. Our process calibration services are geared towards improving overall system performance, product quality, and safety.
Our calibration and maintenance service platform was built to offer our customers a One-Source solution for all their calibration and PM requirements. In order to fulfill this we built a Specialized Calibration Service product line that makes up the third pillar of our calibration department.
NIST Traceable parameters for process calibrations: ●●
Air Flow, CO2, Conductivity, Depth, Dew Point, Differential Pressure, Dissolved Oxygen, Force, Hardness, Humidity, Level, Liquid Flow, Material Count, Metal Detection, pH, Pressure, Rotation, Speed, Temperature, Time, Torque, and more
Process Equipment Calibration Capabilities
We work closely with our customers to develop the onsite expertise designed to drive down the long-term cost of such specialized equipment calibrations.
Specialized Equipment Calibration Capabilities
Autoclave
Depyrogenation Oven
Airborne Laser Particle Counter
UV/VIS Spectrophotometers
Bin, Cage, and Tote Washer
Environmental Monitoring System
Biological Air Sampler
NANO DROP Spectrophotometer
Bioreactors & Fermentor Systems
Extruder Filling Machine
Total Organic Carbon TOC Analyzer
Micro Plate Reader & Washer
Building Automation System (BAS)
AKTA Purifier
Thermo Cycler
Building Monitoring System (BMS) Burst, Friability, & Hardness Testers
Filter Integrity Tester Freezer Dryer – Lyophilizers Heat & Impulse Sealers
AKTA Pilot AKTA Process
Osmometer Validator 2000
Mixer & V-Blenders
CIP & SIP Skids
Packaging Systems
Cleanroom Monitoring System
RO, DI, and WFI Systems
Coating Pan
Waste Systems
go quan t us.c om
Certification Services Our Certification Division specializes in delivering onsite services for routine Cleanroom, HEPA Filtered Equipment, and Fume Hood certifications. Along with our projects group, our Certification Services Division is capable of coordinating large-scale projects and transitioning new builds from construction to operation.
Clean Room Certification Services Our certification services ensure your manufacturing process is operating in an optimal environment, reducing the risk of production-run failures caused by product contamination. Additionally, our certification services provide you with evidence that you are providing a safe working environment for your employees by routinely monitoring noise and light in your clean room manufacturing facilities.
Common types of cleanrooms we certify: Cleanroom Types:
Regulations:
Modular Panel Systems
ISO14644
Soft-wall Cleanrooms
EU Annex 1
Permanent Cleanrooms
USP 797
Containment Suites
HEPA Equipment Certification Services
Fume Hood Certification Services
HEPA filtered equipment certification capabilities include certification in accordance to ANSI, EU, ISO, NSF and USP applicable standards and guidelines.
Fume Hood certification capabilities include certification in accordance to ANSI, EU, ISO, NSF, OSHA and USP applicable standards and guidelines.
Common types of HEPA filtered equipment we certify:
Common types of HEPA filtered equipment we certify:
Bag-In / Bag-Out Units
Isolators
Chemical Hoods
Biological Safety Cabinets (BSCs)
Laminar Flow Benches & Hoods
Total Exhaust Fume Hoods
Clean Air HEPA Snorkel Filter Banks Glove Boxes HEPA Filtered Air Handling Unit
PCR Hoods Sampling Booths & Tents Weigh Booths
go quan t us.c om
Compliance & Technical Staffing Services The Compliance Tech-Staffing Services Division provides our Life Sciences customers a broad range of full-time and part-time solutions for staffing experts knowledgeable in Calibration & Maintenance Program Management, Technical Writing Master Plans & SOPs, CMMS Data Management, and Remediation Services. All of our staffed positions are filled by full time salaried Quantus personnel, taking part in all of the same benefits and training as our administrative and field personnel.
Build or Upgrade Calibration & Maintenance Programs We work with small startup labs and large established corporations to build new Calibration Programs from the ground up or transition from existing basic needs programs to more comprehensive calibration – maintenance databases. We work in a collaborative manner with your system experts to develop comprehensive Standard Operating Procedures (SOPs) that will scale with your operation. Our SMEs often provide guidance and templates for customer writing Master Procedures and Validation Master Plans (VMP).
Data Management Our data management services provide you with the resources required to keep your CMMS up-to-date and compliant to your internal standards. All Quantus employees are full-time salaried. We staff employees certified to manage BLUE MOUNTAIN, as well as support other databases such as PRO-CAL, MAXIMO and custom solutions. ●●
Update equipment status and equipment service history
●●
Verify back-traceability is intact to quickly conduct risk assessments when reference standards are found out of tolerance.
●●
Run periodic reports to assess active, inactive, and past due status
●●
Forecast calibration internal and external workloads on a monthly, quarterly, semi-annual, and annual basis
Remediation Services From time-to-time our customers may need support when implementing corrective actions derived from internal, customer, or regulatory audit observations. We provide support in developing and deploying effective and sustainable solutions for calibration, maintenance, and validation related non-conformance and system improvement events. ●●
Audit the current state of your calibration and maintenance management system
●●
Provide a Validation Master Plan gap analysis and road-map a multi-phase approach to operating in compliance with set standards.
●●
Recommend steps required to improve the system and prevent an audit observation
●●
Provide full or part-time technical staffing services to conduct remediation
●●
Re-deploy a sustainably compliant program
●●
Establish metrics to assess the effectiveness of the changes and sustainability of the program
Long-Term Technical Staffing Support We offer cost effective staffing solutions for routine technical services. Often companies find they have to hire 3 to 5 employees to fill their operational gaps but then find that the work load is not there to cover the cost of this overhead. We provide all the expertise required by supplying the right Subject Matter Expert (SME) at the right time. We are able to supply 3 to 5 SMEs and only bill an equivalent to hiring 1 or 2 full-time employees. This is accomplished by only billing for services rendered as needed for the project and by cost-averaging down cascading skill sets.
Staffing Core Competencies ●●
Staff Calibration Technicians to perform routine Calibration and Preventive Maintenance Services
●●
Staff Certification Technicians to perform monthly Cleanroom, HEPA Equipment, and Fume Hood Certification Services
●●
Staff EM Technicians to perform weekly, monthly, in-process, and personnel sampling
●●
Staff Validation Engineers to provide project management support, document writing, and validation protocol execution services
go quan t us.c om
Environmental Monitoring Services We offer our regulated Life Sciences customers a flexible and cost-effective solution for conducting routine and on-demand Environmental Monitoring Services. Our Microbiologists and EM Service Technicians perform on-site monitoring services, complete your chain of custody and deliver your samples to our 17025 certified micro lab partner.
Routine Microbial and Chemical Sampling Our regulated customers require routine (daily, weekly, monthly) environmental monitoring of their controlled and sterile environments. We provide trained personnel with the best equipment for recovering this critical data and work closely with our micro lab to ensure data integrity with our reliable chain of custody standards in place.
Microbial and Chemical Sampling Capabilities: Cleanrooms
Liquid Samples
Modular Clean Rooms
Soft-Wall Cleanrooms
Biological Safety Cabinets (BSCs)
Controlled Environments
Water Drops, Loops, and Systems
Gowning
Sampling Tents
Personnel
Laminar Flow Hood
Cleaning Verification
Compressed Gas Testing
Steam Quality Testing
Our customers using compressed gas in their clean room and controlled environments require that the quality of any gas or liquid entering the environment must be of equal or better purity then the environment it is entering.
Steam quality testing provides assurance to manufacturers and contract processors of sterile products and medical devices, that their steam system is capable of producing steam compliant to EU and US specifications throughout their sterilization process.
Quantus compressed gas testing engineers provide detailed reports on all gas test points tested and tests are performed in accordance to ISO8573 – Compressed Air.
We offer steam quality testing services in compliance to EU’s EN-285, CFPP 01-01, and US guidance AAMI ST79 and PDA TR#1.
Compressed Gas Testing Capabilities:
Steam Quality Testing Capabilities:
Non-Viable Particle Counts
Oil Content
Non-Condensable Gas
Viable Sampling
Gas Pressure
Dryness
Dew Point Temperature Analysis
Gas Purity
Superheat
Water Content
go quan t us.c om
Validation Services We work closely with our customers in the 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 predetermined specifications and quality attributes”
Facilities and Utilities Validation 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 GMP environment and provide documented evidence in accordance to current industry standards. HVAC
Back Up Generators
Control & Monitoring Systems (BAS / BMS / EMS )
Clean Steam Systems
Temperature & Humidity
Vacuum Systems
Differential Pressure Room Classification – Microbial Particle Counts
Compressed Gas Systems Waste Systems Water Systems (RO / DI / WFI)
Process Validation Our validation service team travels 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 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 endpoint accurately and repeatedly. Aseptic Technique
Gowning Validation
Autoclave / Sterilizers
Heat & Impulse Sealers
Batch Transfers
Label Validation
Bin & Tote Washers
Labelers, Counter, and Inspection Machines
Bioreactors & Fermentors Cleaning Validation Depyrogenation Filling Machines Glass Washers
Packaging Machines Printers Shipping Validation Sterility Validation Tablet Press
Equipment Qualification & Temperature Mapping Services We provide validation services with documentation deliverables designed to provide our customers with evidence which provides a high degree of assurance that their equipment consistently produces results meeting their pre-determined specifications and quality attributes of their process. 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
Refrigerators
Freezers
Stability Chambers
Incubators
Tubing & Bio Welders
Lyophilizers
Ultra-Low Freezers
Mobile and Temporary Storage
Walk-In Storage Units
Ovens (Standard, HighTemp, Vacuum)
Warehouses
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
Micro Plate Washers
AKTA Process FPLC
Nano Drop
AKTA Purifier FPLC
Osmometers
Analytical Balances
Thermocyclers
Micro Plate Readers
UV-VIS Spectrophotometers
Project Management Our validation team is available for short and long-term projects to support facility conversions, improvements, and/or gap analysis with remediation scope development. 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. Initial Walk-Down Scope Development
User Friendly Protocols
Project Proposal
Manage Logistics for Personnel & Equipment Availability/Usage
Defined Timelines for Deliverables Detailed Service Agreements Protocol Development and Approval Routing
Track QA Approvals
Execute Approved Protocols Summarize & Report Data Follow Up & Ensure Satisfaction
go quan t us.c om
Quality Assurance System The quality of our service is of the utmost importance to us. We developed independent systems to support our long- term vision of consistently delivering a superior level of service quality. Our quality management system is an intuitive online system that offers quick access to CAPA, Procedures, and Training Modules, enhancing corporate wide compliance to our quality policies.
Quality Management Our field engineers and technicians use the latest datamanagement technologies to ensure the integrity of the measurement data we collect from our calibration, certification, environmental monitoring, technical-staffing, and validation services everyday. We provide a secure Web-Application for our customers to access the electronic data, service history, and reports that is generated by our onsite services. Key reports can be easily run to review your monthly equipment service requirements keeping you audit ready. ●●
Secure Document Management
●●
Online Technician Training
●●
NCR, CAPA, and resolution management
Audit Ready Reporting: Equipment Due List Equipment Due List By Vendor Past Due List Master Equipment List
Quality Policy Quantus, and its employees are committed to providing quality compliance and technical services and aim to continually improve the services we provide to meet our customer’s requirements. We aim to comply with our commitment stated above by implementing a quality management system that meets the requirements of the international standard ISO 9001. Additionally, we are committed to meeting the requirements of our customers, as well
as legal and regulatory requirements that apply to companies operating in our industry. Quantus, Inc. will continuously monitor and improve our Quality and Operations Systems, in order to sustain a competitive advantage and enhance the quality of our service products. Quantus, Inc. is committed to training all employees and has established an environment of personnel responsibility. We believe in personal responsibility and encourage employees to work together cohesively in order to achieve
our goals efficiently and effectively. Quantus, Inc. is committed to training all employees on both technical and professional aspects of their position, giving them the fundamental tools for success. We work together as a team but recognize individual achievement of success and failure. We take ownership of our work and face difficult decisions and circumstances headon and in good faith to honor our commitment of exceptional service quality to our Customers.
MAIN (866) 876-6537 FAX (480) 247-4927 info@goquantus.com
goquantus.com