vial access iso 13485 antarctica

  • Lyophilised Polymerase Chain Reaction (PCR) Fluorogenics

    Lyophilised Polymerase Chain Reaction (PCR) Fluorogenics a New England Biolabs Inc. Company provides lyophilised molecular biological reagents to the Life Sciences Applied Applications and Clinical IVD Sectors. The team are experts in the design development and validation of molecular reagents specialising in the provision of ambient

  • CertificatesPolymed Medical Devices

    Certificates. The strengths of POLYMED lie in its know-how and perfected technologies. We make user-friendly products by combining the new with the tried-and-tested. Two factors are of outright importance here safety and quality. We have adopted several significant external benchmarks and certifications. The Company has been accredited with

  • Argo Vial Dispensing System for Nuclear Medicine

    2021-8-11 · ARGO 2.0. Vial Dispensing System. Used in GMP Radiopharmacy Radiopharma · For Filling Dispensing Dose Calibration. ARGO is an automatic dispensing system for vials. The equipment is designed and produced to dispense radiotracers used in PET and SPECT diagnosis and therapeutic radiopharmaceuticals. ARGO is a system that complies with the cGMP

  • Corning® Cryogenic Vial Cap Inserts STEMCELL Technologies

    Corning® Cryogenic Vial Cap Inserts come in white blue red green and yellow in a resealable bag. Cap inserts are useful for color-coding vials for easy sample identification. Non-sterile polypropylene inserts are designed to fit most brands of cryogenic vials (e.g. Catalog #38047 38048 38049 or 38053).

  • Certificates of Analysis ATCC

    Certificates of Analysis. Enter the ATCC item number and lot number in the fields below. The lot number can be found on the vial label and is also included on the packing slip this value must be entered exactly as displayed ( i.e. no extra spaces). If you can t find what you need please contact us. ATTENTION ATCC Minis customers please type

  • VC SERIESStainless Steel Vial Container

    2021-7-5 · The vial containers are made of stainless steel with 4 mm lead shielding. The VC comes standard with one adapter for your vial. log in for faster access. Members get access to our on demand and live webinars guides product data sheets catalogues exclusive videos and more. ISO 9001 ISO 13485 Certified Quality System. ISO 45001

  • AT-Closed Vial® Aseptic TechnologiesSafer Easier

    The fully automated vial manufacturing process ensures clean conditions vial and stopper are molded in Grade A/ISO 5 and immediately assembled by robots minimizing particle content compared to other types of primary containers. AT-Closed Vials ® are then packed and sterilized by gamma irradiation being supplied as Ready-to-Fill containers. .

  • SCHOTT Tubular Glass Injection Vials Freeze Drying Vials

    Glass vials produced by SCHOTT using SCHOTT Fiolax ® neutral Type I glass tubing. Standard 13mm and 20mm crimp neck finishes. 100 camera inspection of dimensional parameters. Camera inspection for critical cosmetic defects. Manufactured and packed according to ISO 9001 and ISO 15378. Vials compliant with EP JP and USP.

  • Corning® Cryogenic Vial Cap Inserts STEMCELL Technologies

    Corning® Cryogenic Vial Cap Inserts come in white blue red green and yellow in a resealable bag. Cap inserts are useful for color-coding vials for easy sample identification. Non-sterile polypropylene inserts are designed to fit most brands of cryogenic vials (e.g. Catalog #38047 38048 38049 or 38053).

  • ISO 13485 Medical Device QMS Certification NSF International

    2020-4-3 · Certifying your quality management system to ISO 13485 increases your organization s access to both U.S. and international markets. For example ISO 13485 certification meets Good Manufacturing Practice compliance in the United States. NSF-ISR certifies any organization that manufactures medical devices including unfinished implantable medical

  • ISO 13485 Quality Management System for Medical Devices

    ISO 13485 Medical devicesQuality management systemsRequirements for regulatory purposes addresses the development implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Originally developed in the 1990s the standard details requirements for a quality management

  • IS 1984-2 (2003) Injection Containers for Injectables and

    2018-11-15 · 2) The perpendicularity tolerance a (as defined in ISO 1101) is a limit for the deviation of the plumb-linathrough the centre of tha bottom part and the axis of the vial at the upper edge of the flange it is meaaured at the brim. 3) The manufacturer s trade-mark (optional) may be placed at the bottom of the vial.

  • NewsPrimaPharma

    PrimaPharm Announces Successful ISO 13485 2003 Recertification Audit. March 15 2013PrimaPharm Inc. a contract manufacturer of drugs and medical devices announces the successful completion of its ISO 13485 2003 recertification audit for its production facility located in San Diego California. PrimaPharm has maintained its ISO 13485

  • RABS Isolators Barrier Technology

    2018-2-14 · Vial Nozzle Filling Mechanism HEPA Filters Class 100 (ISO 5) HVAC Class 10 000 (ISO 7) Grade B Grade A Closed RABS –principles This variation has the ability to close a valve to allow a closed system gassing fumigation or bio-decontamination or surface sterilisation.

  • ISO 13485 Quality Management System for Medical Devices

    ISO 13485 Medical devicesQuality management systemsRequirements for regulatory purposes addresses the development implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Originally developed in the 1990s the standard details requirements for a quality management

  • AMD 2019Aseptic Medical

    AMD / Riverside Medical Packaging is BSI accredited to ISO 13485. Manufactured products and packed devices are 100 inspected. In addition they may be subjected to quality checks which are customer or product specific. All orders received pass through our stringent contract review procedure to ensure that exact customer requirements are met.

  • Baby Phill small batch vial filling system Comecer

    2021-8-6 · Baby Phill small batch vial filling system the Comecer approach to the production of small batches for R D Pharmaceutical or ATMP. Members get access to our on demand and live webinars guides product data sheets catalogues exclusive videos and more. ISO 9001 ISO 13485 Certified Quality System. ISO 45001 Health and Safety

  • E-LABELAutomatic Vial Labelling System for Shielded

    2021-7-9 · Automatic vial labelling system for radiochemistry shielded isolators and nuclear medicine hot cells with integrated dose calibrator. Members get access to our on demand and live webinars guides product data sheets catalogues exclusive videos and more. ISO 9001 ISO 13485 Certified Quality System. ISO 45001

  • .2 2 Yukon Medical LLC Vented Single Vial Access Device

    2012-9-10 · Vented Single Vial Access Device 5. 510(k) Summary 5.1. Submitter Information AUG 1 4 2012 Company Name Yukon Medical LLC Company 2200 Gateway Centre Blvd Address biological requirements outlined in ISO 10993-1 ISO 10993-4 ISO 10993-5 ISO 10993-9 ISO 10993-10 and ISO 10993-1l. A summary of these test

  • ARGOS TECHNOLOGIES Polyethylene (PE) Cryogenic Vial PK

    Each vial features linear printed barcodes and a white surface area for specimen identification. Vials are manufactured in a class 7 clean room (class 10 000) in accordance with FDA GMP and ISO quality standards (ISO 13485 2004 ISO 14644 14698) and are certified to be DNase RNase pyrogen ATP and human DNA free.

  • LeadershipT. Korogi P. McNulty T. Fraites Yukon Medical

    2021-4-14 · As Senior Director of Quality and Compliance at Yukon Medical she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820 ISO 13485 and multiple ever-changing international regulations for vial access and IV administration medical devices.

  • CertificatesPolymed Medical Devices

    Certificates. The strengths of POLYMED lie in its know-how and perfected technologies. We make user-friendly products by combining the new with the tried-and-tested. Two factors are of outright importance here safety and quality. We have adopted several significant external benchmarks and certifications. The Company has been accredited with

  • About Packaging Connections Packaging Products Key

    2020-11-9 · Yukon Medical s ViaLok Non-Vented Vial Access devices are used to access standard drug vials for needle-free drug preparation and administration. Technical Features Large diameter fluid lumen giving high flow rate Easy vial attachment and superior vial security Permanent vial attachment nonremovable ISO 594 luer lock

  • CertificatesPolymed Medical Devices

    Certificates. The strengths of POLYMED lie in its know-how and perfected technologies. We make user-friendly products by combining the new with the tried-and-tested. Two factors are of outright importance here safety and quality. We have adopted several significant external benchmarks and certifications. The Company has been accredited with

  • Reagent Preparation Calbiotech

    Access to our expert R D Team Custom packaging options include vial and label specifications a wide range of sizes from 0.25ml2.5L. For bulk liquids we can provide volumes ranging from 250mL500L. Flexibility of batch sizes from 50 to 50 000 vials (serum) with sizes ranging from 0.25ml25ml.

  • ARGOS TECHNOLOGIES Polyethylene (PE) Cryogenic Vial PK

    Each vial features linear printed barcodes and a white surface area for specimen identification. Vials are manufactured in a class 7 clean room (class 10 000) in accordance with FDA GMP and ISO quality standards (ISO 13485 2004 ISO 14644 14698) and are certified to be DNase RNase pyrogen ATP and human DNA free.

  • LeadershipT. Korogi P. McNulty T. Fraites Yukon Medical

    2021-4-14 · As Senior Director of Quality and Compliance at Yukon Medical she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820 ISO 13485 and multiple ever-changing international regulations for vial access and IV administration medical devices.

  • ARGO-T (Transseptal) Closed Vial Dispensing System for

    2021-7-30 · ARGO-T (TRANSSEPTAL) is an automatic dispensing system for closed vials able to fill a vial through rubber stopper. The equipment is designed to dispense radiotracers used in PET and SPECT diagnosis and metabolic radiotherapy. ARGO-T is a system that complies with the cGMP guidelines for filling closed vials. Information request.

  • PVC-0Perspex Vial Container

    2021-7-9 · Perspex vial container for the shielding of beta radiation used in Nuclear Medicine departmens. Members get access to our on demand and live webinars guides product data sheets catalogues exclusive videos and more. ISO 9001 ISO 13485 Certified Quality System. ISO 45001

  • About the Yukon MedicalPreparation Drug Delivery

    2021-4-14 · Yukon Medical is a leading developer of innovative pharmaceutical preparation and drug delivery devices. Yukon Medical was founded in 2008 with the mission to provide clinicians with safe innovative devices for disease detection and medication preparation and administration. Since our inception we have worked directly with clinicians and

  • About the Yukon MedicalPreparation Drug Delivery

    2021-4-14 · Yukon Medical is a leading developer of innovative pharmaceutical preparation and drug delivery devices. Yukon Medical was founded in 2008 with the mission to provide clinicians with safe innovative devices for disease detection and medication preparation and administration. Since our inception we have worked directly with clinicians and

  • NewsPrimaPharma

    PrimaPharm Announces Successful ISO 13485 2003 Recertification Audit. March 15 2013PrimaPharm Inc. a contract manufacturer of drugs and medical devices announces the successful completion of its ISO 13485 2003 recertification audit for its production facility located in San Diego California. PrimaPharm has maintained its ISO 13485

  • ARGO-T (Transseptal) Closed Vial Dispensing System for

    2021-7-30 · ARGO-T (TRANSSEPTAL) is an automatic dispensing system for closed vials able to fill a vial through rubber stopper. The equipment is designed to dispense radiotracers used in PET and SPECT diagnosis and metabolic radiotherapy. ARGO-T is a system that complies with the cGMP guidelines for filling closed vials. Information request.

  • About the Yukon MedicalPreparation Drug Delivery

    2021-4-14 · Yukon Medical is a leading developer of innovative pharmaceutical preparation and drug delivery devices. Yukon Medical was founded in 2008 with the mission to provide clinicians with safe innovative devices for disease detection and medication preparation and administration. Since our inception we have worked directly with clinicians and

  • ASHP Crosswalk of Guidances and Standards for

    Original vial Six hours after initial puncture assuming USP 797 with date/time and vial remains in ISO Class 5 Expects compliance with nationally recognized standards (e.g. CDC USP). Repackaged items

  • StatStrip® and StatStrip® Xpress®2 Glucose/Ketone Meters

    90-day open-vial stability Certifications and Compliance Nova Biomedical is certified to FDA Quality System Regulations and EN ISO 13485 2016 Complies to IVDD Tested according to EN 61010-1 2010 EN 61010-2-101 2015 EN 60825-1/A1 2014.

  • Reagent Preparation Calbiotech

    Access to our expert R D Team Custom packaging options include vial and label specifications a wide range of sizes from 0.25ml2.5L. For bulk liquids we can provide volumes ranging from 250mL500L. Flexibility of batch sizes from 50 to 50 000 vials (serum) with sizes ranging from 0.25ml25ml.

  • T-Vial Shields Mirion Technologies (Capintec) Inc.

    Features. The Tungsten T-Vial shield is more rugged than its lead counterpart. The top features a sliding top that when opened allows access to the encased vial. Vials can be loaded from top or bottom. Get a Quote. Specifications. 0.195″ (.5 cm) thick tungsten shielding

  • LeadershipT. Korogi P. McNulty T. Fraites Yukon Medical

    2021-4-14 · As Senior Director of Quality and Compliance at Yukon Medical she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820 ISO 13485 and multiple ever-changing international regulations for vial access and IV administration medical devices.

  • AT-Closed Vial® Aseptic TechnologiesSafer Easier

    The fully automated vial manufacturing process ensures clean conditions vial and stopper are molded in Grade A/ISO 5 and immediately assembled by robots minimizing particle content compared to other types of primary containers. AT-Closed Vials ® are then packed and sterilized by gamma irradiation being supplied as Ready-to-Fill containers. .

  • ARGO-T (Transseptal) Closed Vial Dispensing System for

    2021-7-30 · ARGO-T (TRANSSEPTAL) is an automatic dispensing system for closed vials able to fill a vial through rubber stopper. The equipment is designed to dispense radiotracers used in PET and SPECT diagnosis and metabolic radiotherapy. ARGO-T is a system that complies with the cGMP guidelines for filling closed vials. Information request.