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Qualification

T3AM’s Qualification

We use a qualification documentation system to monitor commissioning tests (FAT-SAT), optimize non-conformity management, facilitate and speed up reporting processes (review workflow, protocol approval, reports), standardized test protocols.

Activities Conducted for Qualification

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Design Qualification (DQ)

The tests and verification required to be undertaken during commissioning is documented in the ‘Equipment Qualification Plan’ (EOP), which is approved by the end-user prior to initiation of IQ & 0Q activities.

Installation Qualification (IQ)

Documented verification that the equipment or systems are installed or modified.

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Operational Qualification (0Q)

Documented verification that the equipment or systems perform as intended throughout the anticipated operating ranges (an interactive SOP, comes with the IQ/0Q protocol and on completing the requirements specified in the SOP the IQ/0Q protocol is completed).

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Performance Qualification (PQ)

Experienced Commissioning and Performance Qualification (PQ) team has the required technical skills and qualification experience for successful handing over to the customer to start Performance Qualification activities (PQ).

Smooth integration with OEM

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Integration of different process systems and package units
• Multifaceted, integrated automation with OEM systems
• Cross-platform capabilities
• Integrated user security
• Data collection to meet regulatory and internal requirements
• Plant-wide future-proof automation
• CIP /SIP/ Process Integration with various OEM’s Process systems
• Handshaking with Controllers of OEM’s process systems
• Control system audits
• Some of the process system OEMs integrated by us include

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Documentation

From Borescope inspection, video capabilities to Software design specification, T3AM uses different methods to document the designing, fabrication, assembling, and testing of the equipment.

Automation

Some of the best automation engineers of the world work here in one of the leading manufacturers of bioreactors and fermenters, T3AM. All of our services comply with 21 CFR (part 11), GAMP V, and ANSI/ISA-88 standards.

Validation

A well-planned, documented and a managed engineering approach is used resulting in a safe and functional environment to meet established design requirements and stakeholder's expectations.

Explore more process solutions

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Documentation

From Borescope inspection, video capabilities to Software design specification, T3AM uses different methods to document the designing, fabrication, assembling, and testing of the equipment.

Explore more process solutionsG3

Automation

Some of the best automation engineers of the world work here in one of the leading manufacturers of bioreactors and fermenters, T3AM. All of our services comply with 21 CFR (part 11), GAMP V, and ANSI/ISA-88 standards.

Explore more process solutionsG2

Validation

A well-planned, documented and a managed engineering approach is used resulting in a safe and functional environment to meet established design requirements and stakeholder’s expectations.