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At every stage of your project, Sigma ® will partner with you to develop quality standards and processes to meet your specifications.
Quality assurance is driven by Sigma’s quality management systems
(QMS). We have facilities compliant to:
•
ISO 9001:2008 for manufacturing life science research tools
•
ISO 13485:2003 for manufacturing molecular diagnostics
•
21 CFR 820 cGMP QSR for manufacturing molecular diagnostics
•
U.S. FDA registration and 21 CFR 864 ASR QSR for manufacturing laboratory developed test components
Sigma will work with you to develop the content and format for your certificate of analysis to meet your incoming release criteria and streamline your acceptance process.
Good documentation practices are critical to our QMS including detailed batch records for ISO 13485, cGMP, and ASR manufacturing.
Staff are continuously trained to stay current on document and underlying process changes.
Customers who are included in our Change Control Notification program are linked with our Quality Assurance Change Management process for transparency and risk mitigation.
Sigma produces the highest quality chemicals and reagents providing unmatched strength in supply chain management. For externally sourced materials, our supplier qualification program ensures materials meet our exacting standards. Sigma’s enterprise resource planning systems and meticulous record keeping provide complete material traceability throughout manufacturing.
Establishment of confidential disclosure agreements and supply agreements are key to a successful partnership. Our agreements clearly communicate expectations and responsibilities to ensure confidentiality, product requirements, and continuity of supply.
We continually strive to improve the effectiveness of our QMS by eliminating and preventing nonconformances in addition to validating actions taken along with their effectiveness.
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Sigma-Aldrich Custom DNA Primers, qPCR Probes, and Reagents
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From early-stage research through commercial launch, we provide the expertise for custom DNA primer, qPCR probe, and reagent manufacturing to ensure your success.
We believe that accountability, predictability, responsiveness, and flexibility are the keys to project success and customer satisfaction. As a Sigma partner, a project management professional will work with you from the start of the project through order fulfillment.
When your project requires innovative approaches to novel oligonucleotide constructs or formulations, our scientists are available for collaboration in developing:
•
Conjugates and complex dye labeling
•
Customized purification and analytical methods
•
Optimized ready-mixes and customized PCR/amplification enzyme formulations
•
Product and process optimization to maximize manufacturability
•
Component or kit packaging design and private labeling
Process development is a critical step in creating a robust and economical manufacturing process. To set process specifications, we:
•
Identify critical control parameters and risks
•
Develop consistent and reproducible processes
•
Create specifications and manufacturing documents
•
Provide small lots for stability testing, design verification, and design validation
•
Manufacture the necessary pilot batches to achieve production scale
Sigma can develop unique methods or adopt your existing protocols to meet your specifications. Sigma’s expertise in methods transfer ensures your proven analytical procedures are integrated into our quality systems. Our multi-million dollar investment in state-of-theart instrumentation and our experienced team of scientists are the foundation for our development and qualification process.
Manufacturing Overview
Development
Project Management
Manufacture
Project
Requirements
Product
Development
Support
• Sign Confidential
Disclosure Agreement
• Assign Project Manager
• Determine Specifications
• Create Synthesis
Strategies
• Optimize Product
• Design Packaging
Process
Development
Custom
Manufacturing
Support
Services
Global
Distribution
• Identify Risk
• Develop Reproducible
Process
• Manufacture Pilot Lots
• Capacity Planning
• Flexible Automation
• Custom Packaging
• Dedicated
Customer Service &
Operations Team
• Regulatory &
Compliance Services
• Business Reviews
• Supply Agreements
• Supply Chain
Management
• Logistics Support
For more information, visit sigma.com/compliantoligos 3
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Sigma has the personnel, infrastructure equipment, and facilities to handle all of your manufacturing requirements.
Sigma’s robust manufacturing processes are designed with our customers in mind. Our flexibility in manufacturing results from our technical expertise and core manufacturing capabilities, including:
•
Flexible automation
•
Range of production scales
•
Stringent quality control
•
Laboratory Information Management System (LIMS)
Sigma understands that consistency is critical to manufacturing success. Our engineers design and maintain proprietary synthesis platforms, processing equipment and facilities. Instruments are qualified and an extensive preventive and predictive maintenance program ensures optimal performance. Utilizing our in-process controls and LIMS to capture information, process adjustments can be made in real time.
Sigma’s manufacturing expertise makes us the partner of choice for designing and creating solutions for all your production needs.
Sigma can formulate the most complex components with precision and accuracy. We have the ability to:
•
Formulate liquids and dry powders on a small to large scale
•
Accommodate a variety of packaging configurations including microtiter plates, tubes and bottles
•
Package a single component or an entire kit to your specifications
•
Private label your product
Sigma’s commitment to its partners is evident in all aspects of our business. We routinely tailor programs to meet customer requirements including:
•
Functional testing of your product
•
Regulatory compliance consulting
•
Audits of Sigma facilities
•
Forecasting and capacity planning
•
Quarterly business reviews
•
Account-specific Key Performance Indicators (KPI)
•
Inventory management services
•
Global warehousing and distribution
To learn more, visit sigma.com/compliantoligos
Enabling Science to
Improve the Quality of Life
Order/Customer Service: sigma-aldrich.com/order
Technical Service: sigma-aldrich.com/techservice
Development/Custom Manufacturing Inquiries safcglobal@sial.com
Safety-related Information: sigma-aldrich.com/safetycenter
©2013 Sigma-Aldrich Co. LLC. All rights reserved. SIGMA, SAFC, SIGMA-ALDRICH, ALDRICH and SUPELCO are trademarks of Sigma-Aldrich Co. LLC, registered in the US and other countries. FLUKA is a trademark of
Sigma-Aldrich GmbH, registered in the US and other countries. Sigma-Aldrich, Sigma, Aldrich, Supelco, Fluka and SAFC brand products are sold by affiliated Sigma-Aldrich distributors. Purchaser must determine the suitability of the product(s) for their particular use. Additional terms and conditions may apply. Please see product information on the Sigma-Aldrich website at www.sigmaaldrich.com and/or on the reverse side of the invoice or packing slip.
World Headquarters
3050 Spruce St.
St. Louis, MO 63103
(314) 771-5765 sigma-aldrich.com
LSW
81407
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