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PTFE Septa for Pharmaceutical Applications: Maintaining Sample Integrity and Regulatory Compliance

Sample handling solutions – Aijiren Tech Sci make PTFE/silicone septa suitable for all types of chromatographic applications . A thin film of PTFE is laminated to the side of the septum that faces ...
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Sample handling solutions - Aijiren Tech Sci

make PTFE/silicone septa suitable for all types of chromatographic applications . A thin film of PTFE is laminated to the side of the septum that faces the sample to limit exposure of the elastomer to the solvent . PTFE/Silicone septa are ideal for use in most HPLC and GC applications where resealability and purity are critical . Pre-slit PTFE

Accessory Product Data Sheet - .NET Framework

PTFE/Red Rubber Septa: PTFE/Red Rubber septa are the most popular and economical choice for general gas chromatography applications. These septa are used primarily for routine analysis in gas chromatography with FID, TCD and FPD detectors. PTFE/Red Rubber offers moderate resealability and excellent chemical inertness before puncture.

Septum Selection Guide Rev 2 - Aijiren Tech Sci

Septum Selection Guide Septa for use with general chromatography vials PTFE/Red Rubber Septa: (PTFE/RR) PTFE/Red Rubber septa are the most popular and economical choice for general gas chromatography applications. These septa are used primarily for routine analysis in gas chromatography with FID, TCD and FPD detectors.

11 mm Pre-Assembled Silver Aluminum Crimp Cap with PTFE

Our closures with septa are made in a wide variety of sizes and materials ensuring you have the right combination for your sample type and analysis temperature. Each product is manufactured using strict quality control standards resulting in consistent cap dimensions with septa which may be certified for higher purity grades.

Data Integrity and Data Quality in Application Submissions

www.fda.gov 4 Importance of Data Integrity • The integrity and quality of data in application submissions are critical concerns of FDA • Poor data quality, whether due to sloppiness or

Article 56: An In-Depth Guide: 137 Frequently - LinkedIn

Jul 11, 2023 · Yes, Pre-slit PTFE/Silicone Septa are designed to withstand multiple injections without significant deterioration, maintaining their integrity and preventing sample loss or contamination.

Safeguarding Vial Container Closure Integrity: A Systematic

Oct 5, 2023 · Primary packaging plays a critical role in maintaining drug quality and full regulatory compliance throughout the product’s shelf life. A vial container closure system for pharmaceutical, biological, cell, and gene therapies must maintain container closure integrity to ensure that the drug products remain stable and free of contamination from microbial ingress.

Aijiren Tech™ SureSTART™ HPLC and GC Certified Screw

Select Level 3 products for ultimate performance and sensitivity from your methods, while maintaining the highest levels of sample security and integrity. Choose from a variety of kits containing short thread screw vials with marking spots in clear or amber glass and polypropylene caps with silicone/PTFE septa designed to reduce autosampler

Premium PTFE and Silicone Septa: Reliable Sealing Solutions

Whether in analytical laboratories, pharmaceutical research, biotechnology, or environmental testing, PTFE/Silicone septa play a vital role in maintaining sample integrity and ensuring accurate results. Product Description. Our PTFE/Silicone septa are meticulously crafted using high-quality materials to guarantee superior performance.

What Is Regulatory Compliance? - Definition, Plan & More

Regulatory compliance describes the actions an organization takes to comply with those rules and policies as part of its operations. When it comes to data, there are rules for handling sensitive information. To be in regulatory compliance, organizations set up internal processes to keep data safe and secure. Otherwise, they can be fined, sued

For HPLC Vial Caps and Septa, you need to know

Oct 21, 2022 · Oct. 21st, 2022. The septa and vial caps are essential parts of HPLC vials. The vial cap serves as a barrier, keeping outside contaminants out of the vial and preserving the integrity of the sample. The septa, a seal between the injection needle and the vial composed of silicone, PTFE, or rubber, ensure accurate and exact sample injection.

SureSTART™ MSCERT+ Screw Vial and Cap Kits, Level 3 High

Select Level 3 products for ultimate performance and sensitivity from your methods, while maintaining the highest levels of sample security and integrity. Choose from a variety of kits containing short thread screw vials with marking spots in clear or amber glass and polypropylene caps with silicone/PTFE septa designed to reduce autosampler

Compliance in pharma industry: challenges & solutions | Within3

May 28, 2021 · This makes pharma compliance one of the topmost priorities for companies. The ramifications of not complying with regulatory affairs in pharma can be serious, including significant financial judgments and even legal and criminal consequences. Due to the risk of non-compliance and other threats to the pharmaceutical industry, drug developers

Septum Selection Guide Vials and Closures - Aijiren Tech Sci

PTFE/ Synthetic Red Rubber septa are an economical choice for general GC and HPLC applications. Used primarily for routine analysis in gas chromatography with FID, TCD and FPD detectors or HPLC with UV/Vis or RI detectors, PTFE/Synthetic Red Rubber septa offer good resealability and excellent chemical inertness before puncture.

Regulatory Compliance in Pharmaceuticals | Linguamatics

Nov 29, 2022 · IDMP Compliance. Data-Driven Quality Risk Management and Compliance. The pharmaceutical industry is among the most heavily regulated in the world. Linguamatics Natural Language Processing (NLP) can bring time-saving benefits for regulatory compliance compared to manual efforts, which are often slow and expensive.

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Zhejiang Aijiren Technology, Inc. is a global supplier of life-science, chemistry, laboratory consumables, etc. Our major products are high performance liquid chromatography & gas chromatography consumables such as Chromatography Autosampler Vials with closures, inserts, crimper and syringe filters, etc; Water analysis consumables such as COD test tube.
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