Service & Validation

Service

PHCbi is a leader in the laboratory and life science equipment industry through the quality of our products and the skill of our extended service team. We deliver validation and product services through an extensive network of service experts throughout the nation. Our service partners are trained regularly by experts from PHCbi to ensure quality is maintained.

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Services

We help you to protect your results!

Years of experience have taught us what is important to support your work. We have developed a series of standard packages that provide excellent service against any reasonable budget. There are also possibilities to tailor a maintenance plan for every customer need.

Services

In addition to our technical specialists’ extensive experience with PHCbi brand products, we have experience in maintaining other brands from maintenance in the warranty period, to all-inclusive contracts with multiple visits per year. We help you stay ahead of possible problems by keeping your equipment in excellent condition. During preventative maintenance, the equipment is thoroughly inspected according to manufacturing specifications and recommendations.

PHCbi Laboratory Products

As a leader in environmentally controlled products, PHCbi offers a full line of laboratory equipment designed for use in the life science market. Our level of standards for product safety, reliability and high performance are well known in the industry. Self-diagnostics, included on our products, permit authorized service technicians to determine how and when service calls are required. Because our products are sold and serviced worldwide, products acquired in one country under grant or facility-sharing programs are easily supported if moved to facilities in the next city or around the world. Choosing PHCbi brand as an equipment and validation service provider can greatly reduce the time and cost of equipment compliance verification. We also offer training to selected facility biomedical engineers and service staff authorized in warranty and post-warranty repairs.

Validation Services

Advanced technology and contemporary processes assure compliance through in-depth validation. PHCbi offers a turnkey, systemized approach to validation and compliance. We provide solutions using ISO/NIST calibrated instrumentation for validation and qualification in accordance with current GxP regulations (GMP, GLP, GCP), local standards and other regulations.

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Professional Validation

Our team of experienced factory authorized validation service professionals have earned a reputation for professional performance, detailed documentation and outstanding support for our customers. Validation solutions incorporate data collection and analysis protocols to provide complete and accurate validation reports. All archived data is customer specific with secure backup. We meet international requirements for inspection of pharmaceutical, biotechnology, and medical device manufacturing. We use a wired process validation system designed around measurement and reporting requirements of the most intensely regulated industries.

Available Validation Services

On-Site Validation/Qualification

 
  • IOQ (IQ/OQ) Protocol Execution
  • Calibration (ISO or NIST)
  • Performance Qualification (PQ)
  • Validation support
  • Consultation
 
(*Menus for custom validation services provided vary by country. Please contact your local distributor for details*)
 

Pre-delivery Validation/Qualification

 
  • Factory Acceptance Testing (FAT) Protocol Execution
  • Calibration (ISO or NIST)
  • Performance Qualification (PQ)
  • Validation support
  • Consultation
 

Custom Validation

Customized Temperature mapping options include but are not limited to:

  • Loaded Chamber mapping
  • Open Door/Recovery mapping
  • Power Failure/Recovery mapping (temperature pull-up)
  • Temperature pull-down mapping
  • Additional temperature sensor positions
  • Extended logging periods – greater than 24 hours
 
(*Menus for custom validation services provided vary by country. Please contact your local distributor for details*)
 
 

Validation Protocols

  • Unit specific manufacturer authorized protocol documents
  • Traceable to unit model and serial number
  • Customizable testing procedures to meet customer specific requirements
  • May be purchased separately for in-house or local vendor execution

Factory Acceptance Testing (FAT)

FAT is performed on the equipment at the PHCNA facility prior to shipping. FAT covers verification of unit conformance to manufacturing specifications including verification of unit assembly and operation.

Validation Solutions

Validation Solutions

Installation/Operation Qualification (IOQ)

IOQ is performed on the equipment at your facility. IOQ covers verification of unit conformance to manufacturing specifications including verification of unit assembly and installation (IQ) and verification of unit operation (OQ).

Performance Qualification (PQ)

Performance Qualification challenges the unit by subjecting it to “real world” operational situations for data capture and evaluation. Performance Qualification may include any combination of custom validations like Loaded Chamber Temperature Mapping, Open Door/Recovery Testing and Power Failure/Recovery Testing.

Unique Solutions

Our flexibility to meet your needs and our knowledge of regulatory expectations guide our mission to provide professional and successful completion of our services. Beyond meeting established standards, guidelines and tolerances, we accommodate unique customer application needs. If a service, validation or qualification you require is not listed, please contact us for assistance.

Laboratory Equipment Parameters

Whatever your validation needs, we can provide comprehensive expertise in laboratory equipment to meet your needs.

Laboratory Equipment Parameters
Product Temperature CO2 O2 Humidity
-%RH
Pressure
ULT Freezers
 
Cryogenic Freezers
 
Laboratory Freezers
 
Pharmaceutical Storage Freezers
 
Plasma Storage Freezers
 
Laboratory Refrigerators
 
Blood Bank Refrigerators
 
Pharmaceutical Refrigerators
 
Incubators
 
CO2 Incubators
 
 
CO2/O2 Incubators
 
 
 
Environmental Chambers
 
 
Regular scheduling of calibration and preventive maintenance is required to trace performance and ensure the accuracy of your equipment.

Calibration

Validation Services offer compliant calibration to meet your validation and qualification needs. Calibration confirms and verifies that all displayed values and control parameters are within the manufacturer's tolerances to ensure proper operation at exact set points.
Validation instruments are calibrated to ISO standards and adhere to a regular schedule of calibration and preventive maintenance for ongoing compliance. Test equipment calibration certificates are available on all projects.

 

Our Professional Expertise

Our validation staff can help you with planning and developing your validation strategies. With our extensive knowledge and experience we offer:

  • More than 30 years of combined validation experience in the strictest GxP environments
  • Field service and service engineering
  • 60 years of combined service experience in the laboratory equipment market
  • Unbiased testing of competitive equipment
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PHCbi Laboratory Products

As a leader in environmentally controlled products, PHCbi offers a full line of laboratory equipment designed for use in the life science market. Our level of standards for product safety, reliability and high performance are well known in the industry. Self-diagnostics, included on our products, permit authorized service technicians to determine how and when service calls are required. Because our products are sold and serviced worldwide, products acquired in one country under grant or facility-sharing programs are easily supported if moved to facilities in the next city or around the world. Choosing PHCbi brand as an equipment and validation service provider can greatly reduce the time and cost of equipment compliance verification. We also offer training to selected facility biomedical engineers and service staff authorized in warranty and post-warranty repairs.

 
PHC Corporation of North America

PHC Corporation of North America is a leader in laboratory equipment for the biopharmaceutical, life sciences, academic, healthcare and government markets. Product lines under the new PHCbi brand include the space saving and energy efficient VIP® ECO, TwinGuard® and VIP Series ultra-low temperature freezers, cryogenic and biomedical freezers, pharmacy and high performance refrigerators, cell culture CO2 and multigas incubators and Drosophila/plant growth chambers. PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, which is a global healthcare company involved in the three core businesses of Medical Devices, Healthcare IT and Life Sciences. For more product information, please call PHC Corporation of North America at 800-858-8442.