Service & Validation Service & Downloads

Service

At PHCbi, we remain leaders in our industry by ensuring that the quality of our products are maintained. With product and validation services available to you through our extensive network of service experts, you don’t have to worry about getting the proper service for your equipment in a timely manner. To ensure all our products are being serviced and validated appropriately, we also believe in providing education on maintenance and repair to qualified individuals and institutions.

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Services

We help you to protect your results!

Regular maintenance and inspection is important for properly functioning technical installations. You have already decided to use PHCbi Biomedical equipment, which is characterized by the highest quality and reliability. However, when it comes to the technical support of this equipment, our service, dedication and customer-friendliness are just as high.

What service do we offer to maintain this high level of reliability? Thanks to our years of experience, we now know what our customers think is important, and we have developed a series of standard packages that contain all the possibilities for excellent service against any reasonable budget. Of course there are also possibilities to tailor a maintenance plan for every customer needs.

Services

Our technical specialists are of course fully familiar with the PHCbi products but have gained a lot of experience over the years with previous brands in terms of maintenance and repair. From maintenance in the warranty period to all-inclusive contracts with multiple visits per year. With these maintenance packages, we help you to stay ahead of possible problems by keeping your equipment in excellent condition. During this preventive maintenance, the equipment is thoroughly inspected according to the latest information and recommendation from the PHCbi factory in Japan. And your devices will continue to perform optimally after the maintenance.

When purchasing any PHCbi Biomedical product, you as a customer always ensure the constant service backup of a fully trained and factory certified PHCbi technician who knows what needs to be done in every situation.

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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 turnkey solutions using ISO 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 trained validation service professionals have earned a reputation for professional performance, detailed documentation and outstanding support for our customers. Validation solutions incorporate a data collection and analysis protocol 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

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

Custom Validation

Customized options include but are not limited to:

  • Temperature mapping
  • Loaded Chamber mapping
  • Open Door/Recovery mapping
  • Power Failure/Recovery mapping (temperature pull-up)
  • Temperature pull-down
  • Additional temperature sensor positions
  • Extended logging periods – greater than 24 hours
Validation Services
(*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

Validation Solutions

Validation Solutions

Installation/Operation Qualification (IOQ)

IOQ is performed on the equipment at the customers’ 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

Validation Services

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.

Validation Services

Our Professional Expertise

Our validation staff can help you with planning and developing your validation strategies. With our deep 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.