QMasterTM GS II  [Gram Scale]
Diagnostic Scale - Pilot Scale
Multi-Column RNA/DNA Synthesizer

3 column - 9 monomer reservoirs

LIST PRICE $175,000.USD 
(base system)

Engineered for the discerning, uncompromising customer who requires the highest degree of precision in a synthesis platform necessary for assembling biomolecules such as siRNA's.


The QMaster GS II is a Custom DNA/RNA, siRNA synthesizer designed to operate with superior efficiency at scales in the 140umole to 5mmole range. A variety column geometries and resin loadings can provide an increased synthesis range.

This system operates with a single multi-speed gear pump, which affords high reliability and producers higher quality oligomers over conventional systems developed from a liquid chromatograph purification systems.

The turbulent nature of the gear pump provides for enhanced pre mixing of reagents prior to delivery to the reactor. This is essential for high quality oligonucleotide production.

 

The system can synthesize DNA, RNA and hybrid molecules and along with the standard nine monomers reservoirs. This system can deliver up to 5 ancillary reagents and wash to the three column reactors at a variable flow rates.

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The system utilizes a fixed bed, flow through column reactor. The size show in this photograph is capable of scales ranging from 250umole to 700umole. Additional column reactors are available that will provide scale range from 140umole to 5mmole or greater depending on the support loading. Coupling excess requirements are between 3 and 10 fold which is highly competitive with industry standards. Cycle times are approximately 12 minutes for standard DNA coupling and slightly longer for RNA

The new higher loaded supports offered today provide extended scale capabilities.

System control is based on Genomic's Validate TM software.

The system makes use of several onboard sensors to control key synthesis operations. As the synthesis environment of your oligonucleotide changes the system adapts to provide the optimal coupling and deprotection efficiencies.

 

QMaster GS Reagent Consumption for RNA synthesis
Scale *100  umoles # 250  umoles #500  umoles
Column Volume 30  ml 20  ml 40  ml
WASH 502.5ml 335.0ml 670.0ml
Deblock 54.9ml 37.0ml 64.0ml
Activator 25.0ml 23.8ml 37.6ml
Monomer 5.0ml 5.0ml 12.5ml
Cap A 15.0ml 10.0ml 16.0ml
Cap B 15.0ml 10.0ml 16.0ml
Oxidizer 7.5ml 5.0ml 18.0ml
* Using Low Loading  support # Using High Loading support (>70umole.gm) # Using High Loading  support (>70umole.gm)
Key Features For GMP Operation
  • All system operations are logged for a complete process record. 
  • The system is equipped with on-board diagnostics, which enable system validation prior to synthesis operation.
  • The system is equipped with a security module that limits control of the synthesizer to authorized users. The security module provides multiple level user access including supervisor, operator and technician levels, in compliance with FDA, CFR Part 11.
  • Keyboard and Mouse are Bluetooth enabled for operation away from wetted areas.

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Regarding: Title 21 CFR Part 11

From Wikipedia
Title 21 CFR Part 11
of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.


The OligoMaster II is designed to assist biotech companies, biologics developers become part 11 compliant. The system comprises several elements toward this goal.
The system can be run in "Secure Mode". This mode addresses the needs of the electronic signatures and limited control. Secure Mode requires that all operators, administrators and service persons log into the software before they can perform operations on the system. The specific operations are limited to the type of user that is logged in. For instance only an Operator type user can perform a synthesis and only a Service type of user can perform diagnostics. All users are automatically logged out after a period of inactivity.
  • The system comprises several onboard diagnostic routines that went successfully run can qualify the system parametrically.
  • The system logs every operation whether it be a synthesis, a diagnostic or manual function. This is essential for audits.
  • The system comprises several sensors that control the operations of key steps in the protocol. These sensors provide "closed loop" confirmation of optimal operation while enhancing precision.
  • An optional "Validation Documentation Pack" is available that includes IQ, OQ, PQ, System Requirement Specification , Software flow Diagram, User Requirement Document, test protocol and a Software Execution block diagram, which are critical documents necessary for ISO compliance.

 

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