Field Services and Qualification

Field Services &
Qualification

Custom Biogenic Systems (CBS) offers comprehensive Field Services and Qualification for our cryogenic storage systems, including Isothermal, Standard, and Controlled Rate Freezers (CRF).

Our factory-trained service team helps ensure your equipment operates as designed—supporting sample integrity, regulatory compliance, and operational confidence.

Whether you are commissioning new equipment or maintaining an installed fleet, CBS provides preventative maintenance, calibration, and IQ/OQ qualification services tailored specifically to CBS-manufactured systems.

All maintenance is performed by technicians trained specifically on CBS equipment—ensuring accurate service aligned with original design specifications.

Preventative Maintenance for Cryogenic Systems

Routine preventative maintenance is critical to long-term cryogenic system performance and uptime. CBS Field Services are designed to reduce risk, identify issues early, and extend equipment life.

Service support for all CBS-manufactured equipment
- Isothermal Cryogenic Storage Systems
- Standard Cryogenic Storage Systems
- Controlled Rate Freezers (CRF)
Temperature probe recalibration
LN₂ level sensor recalibration
(Isothermal and Standard models only)
Multi-point inspection of mechanical, electrical, and control components
General functionality testing to confirm system performance

Installation Qualification & Operational Qualification (IQ/OQ)

CBS provides Installation Qualification (IQ) and Operational Qualification (OQ) services to support regulated environments, qualification requirements, and internal quality systems.

Our IQ/OQ protocols are developed specifically for CBS cryogenic platforms and are executed by experienced qualification professionals.

Why Choose CBS Field Services?

Our factory-trained technicians with cryogenic expertise utilize validation protocols specifically developed for CBS systems to deliver services aligned with regulatory expectations, providing consistent documentation and a single source for all your support needs.

IQ/OQ for Isothermal & Standard Cryogenic Systems

CBS offers a 36-page detailed IQ/OQ protocol that includes the following topics:

Qualification of proper installation and configuration
Comprehensive alarm testing across all alarm conditions
24-hour empty chamber temperature mapping
5-minute open-lid recovery testing to evaluate system stability after access events

These protocols help demonstrate consistent performance and recovery characteristics critical for sample protection.

IQ/OQ for Controlled Rate Freezers (CRF)

Controlled Rate Freezers require deeper validation due to software control and process complexity. CBS provides a 92-page detailed IQ/OQ protocol specifically for CRF systems, including:

Software qualification documentation
Alarm testing and qualification
Three (3) trial freeze runs
Independent validation using Kaye Validator systems to confirm chamber temperature accuracy during freeze cycles

This process supports customers operating under GMP, GxP, and internal quality requirements.

Request Cryogenic Field Services
or
Qualification Support

Whether you are planning a new installation, an upcoming qualification event, or a routine preventative maintenance visit, the CBS Field Services team is equipped to assist you.

Contact Custom Biogenic Systems today to arrange:

Preventative maintenance scheduling
Recalibration of temperature or LN₂ sensors
IQ/OQ qualification services
Controlled Rate Freezer qualification

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Cryogenic Field Services & Qualification Questions

Field Services & Qualification