vial access iso 13485

  • Vial Adapterspdfs findtheneedle

    BS EN ISO 13485 Vial Adapters Order Code Description Supplied Sales Unit IV72024 20mm MLL Vial Adapter compatible with West Vial2Bag IV system Sterile 150pcs/pk of the contents during repeated vial access With an effective drip free system and swabable surface area the adapter opens only when connected to a standard luer

  • 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

  • Radiopharmaceutical Dispensing Isolator for Vials and

    The Phaedra Isolator ensures high ergonomics and operative rapidity in pre production stages introduction of vials syringes and disposable in the aseptic area and post production stages removal of disposable and cleaning ensures flexibility during management and extraction of final containers either in vial format or as syringes or cartridges thanks to the new universal extraction

  • 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

  • Re Ordering Codonics

    SKU 1SCA SLX33 4 This kit contains four rolls of blank white labels for the Codonics Safe Label System SLS model SLS 500i Using the SLS the syringe label information prints automatically from a barcode scan of the drug vial and preparation information Each roll of labels contains 1000 labels They are used in the Codonics SLS 500i for

  • NOV 6 2012

    An ISO 13485 International Company in r nrr irs 3232 N Rockwell Street Chicago Illinois USA Phone e Fax devices 1 SmI anesthetic vial 1 8m1 anesthetic vial Reprocessing and 0 Tested in accordance with ANSI/AAMI 0 Tested in accordance with ISO

  • Compliance Certification VWR

    ISO 13485 The ISO 13485 standard specifies the requirements for a comprehensive quality management system for the entire life cycle a o production sales and supply of medical devices and in vitro diagnostics ISO 17025

  • glass vial manufacturers bactrimReal Estate Go

    ISO 9001 ISO 14001 ISO 9001 IATF16949 ISO 13485 The Gx Elite vials are the result of a careful product development process spanning several years Glass vial manufacturers often produce more than just glass vials as the equipment used to make them are the same as those needed for glass bottles glass equipment and other medical glass based

  • Yukon Medical LLC Receives ISO 13485 Certification

    Yukon Medical has also obtained a certificate for CE Marking its ViaLok Vented Vial Access Devices Achieving ISO 13485 certification is a major milestone for Yukon Medical

  • AMDBD Syringes Fitted with BD Microlance 3 Needles

    The whole range of products is CE marked and certified under ISO13485 AMD are always able to offer bespoke pack solutions such as different quantities per pouch or combinations of devices to meet specific procedure requirements bringing flexibility and scalability to any manufacturing process Vial Access

  • Aseptic Processing Fill Finish Equipment by SP i

    The SY BI LI series is a line of filling equipment for injectables oral ophthalmics syringes and cartridges Vial filling up to 200 vials per minute The Aseptic filling series is made up of multiple models to cover a wide range of applications for the pharmaceutical industry

  • 2 2 Yukon Medical LLC Vented Single Vial Access Device

    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 ISO ISO ISO ISO and ISO l A summary of these test

  • NewsPrimaPharma

    High Recovery Vials are a specialty vial with a V bottom that allows for a syringe to fully access the contents of the vial with a syringe This type of vial is important for High Value/High Cost drug products so that nonoe of the drug product is wasted ISO 13485 2003 certifies that a quality management system has been

  • Manufacturing Sterile Barrier Systems for the

    In Europe EN ISO 11607 Part 1 replaced EN 868 1 1997 while EN 868 parts 210 have been referenced as informative documents in EN ISO 11607 Where packaging is covered by one or more of EN 868 parts 2 10 they can be used to demonstrate compliance with the new EN ISO standard

  • ISO 2015 en Safety of amusement rides and

    You have to enable javascript in your browser to use an application built with Vaadin ISO 2015 en Safety of amusement rides and amusement devices Part

  • Aseptic Processing Fill Finish Equipment by SP i

    The SY BI LI series is a line of filling equipment for injectables oral ophthalmics syringes and cartridges Vial filling up to 200 vials per minute The Aseptic filling series is made up of multiple models to cover a wide range of applications for the pharmaceutical industry

  • PVC 0Perspex Vial Container

    2 days ago 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

  • Borla Inc Medical Device Supplier Directory

    A division of Borla Yukon Medical is an ISO 13485 certified and leading developer of innovative pharmaceutical preparation and delivery devices with a focus on reconstitution at the point of care and injectable drug delivery These include our ViaLok Non Vented Vial Access devices ViaLok Vented Vial Access devices Arisure Closed

  • 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

  • DocumentsProduct Brochures Specifications Product

    High Pressure Flow Control Switch Manifolds Stopcocks with Extension Tubing Luer Activated Valves Check Relief Valves Close Molded Parts Components Molded Parts Components Neuraxial Components ISO

  • LeadershipT Korogi P McNulty T Fraites Yukon Medical

    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

  • IS 1984 2 2003 Injection Containers for Injectables and

    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

  • ISO 2009 en In vitro diagnostic medical devices

    This part of ISO 18113 contains a comprehensive list of terms and definitions necessary to develop the labelling for IVD medical devices Internationally agreed upon definitions of important concepts promote greater consistency in IVD medical device labelling While the goal is to standardize the terminology used in IVD medical device labelling to the extent possible it is also recognised

  • Needle Needle Free Injection Ports Sites Qosina

    Vial access adapters are available for 13 mm and 20 mm vials with an adjustable vial adapter to fit 13 mm to 20 mm vials also available We help get your innovations to market with over 5 000 components in stock at our 95 000 square foot ISO 13485 ISO 22301 ISO 9001 and ISO 14001 registered climate controlled facility with a Class 8

  • GMP Audit ReportPro QC

    certified to ISO 13485 and CE Registered to FDA and compliant to GMP 2 Should keep a record of cleanliness as well as record of environment control up to date and readily available DMR files are maintained for project developed and fully compliant to the requirement of 820 181

  • Cleanroom Cleaning and Gowning Protocol GuideISO

    A ISO Class 5 Cleanroom formerly Class 100 is an atmospheric environment that contains less than 3 520 particles 0 5 microns in diameter per cubic meter of air formerly stated as 100 particles 0 5 microns in diameter per cubic foot of air B ISO Class 7 Cleanroom formerly Class 10 000 is an atmospheric environment that contains less than 352 000 particles 0 5 microns in

  • 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

  • Certificate of Registration of Quality Management

    feeding valves vial access devices infusion sets monitoring devices and sterile leur access valve disinfectant cap The manufacture repair and servicing of optical modules for oxygen measurement Irradiation sterilization of medical devices in accordance with ISO 2006

  • ISO 39001 case studies BSI

    ISO 39001 Road Traffic Safety Management case studies BS ISO 39001 provides a framework for developing a road traffic safety management system Benefits of implementing the standard include contributing towards a reduction in road traffic accidents lower repair bills reduced insurance premiums and social responsibility enhancements

  • Dispensing Pin Vial Adapter Needleless #YM020 Yukon

    ViaLok Vented Vial Access Device The ViaLok Vented Vial Access Device is designed with a 0 2 micron filter to allow for venting during fluid withdrawal 20 mm standard closure Universal Easy attachment and superior vial security Integrated grip reduces user

  • Filled in F48/F49 for internal audit ISO 17025 2017

    Good evening guys I work for a civil laboratory and we test soils concretes aggregates etc We use SANAS F48 management and F49 technical to do our internal audits and I would like to know if anyone has a fully filled in one with all the CAB/Auditors information of

  • About the Yukon MedicalPreparation Drug Delivery

    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

  • Good Manufacturing Practices GMP Products and Services

    Custom Services We understand that cell manufacturing processes are optimized for individual outcomes We will work with you to develop and deliver GMP raw materials and services that meet your specifications We can provide customized vialing as well as

  • STOP PRESS STOP PRESS STOP PRESS STOP

    the Vented Vial Adapter is evaluated against a selection of drugs known to adversely affect the performance of other polymeric devices Compatible with standard 13mm and 20mm vials each device utilises a non coring plastic spike surrounded by a snap on skirt to securely fasten onto vial tops granting stable luer lock access to a syringe

  • Bearing nsPVA Embolization ParticlesPrecise Calibration

    Bearing nsPVA Embolization Particles are irregularly shaped biocompatible hydrophilic nonresorbable particles produced from polyvinyl alcohol These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters

  • APIC Position Paper Safe Injection Infusion and

    Cleanse the access diaphragm of vials using friction and 70 alcohol or other antiseptic Allow to dry before inserting a device into the vial Discard single dose vials after use Never use them again for another patient If a multidose vial must be used it should be used for a single patient whenever possible