Process Validation

Medical Device Process Validation Services

BMP Medical offers full medical device process validation services for all of our customers. We will work individually with a project manager and your team to develop a validation master plan for your project. The plan can range from simple go/no go to a full IQ/OQ/PQ protocol. We customize the plan based on the customer’s needs and requirements. Many of our customers require full statistical data analysis for their project, and we use the latest software to provide cPk and pPk. We also use an automated vision system to measure parts and can provide gage R&R testing as part of the validation. When necessary, BMP Medical partners with several metrology houses for high volume measurements, or for measurements that are beyond our internal capabilities.

WE OFFER

  • Validation Master Plan
  • IQ, OQ and PQ Protocol
  • Data Analysis with Minitab Statistical Software

 

  • FMEA Process
  • Keyence Vision System
  • First Article Samples

Creating pathways for successful outcomes

READY TO GET STARTED?

    Plastic Products Catalog

    BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

    Non-Sterile and Sterile Centrifuge Bottles

    • Available with standard caps for low-speed work and sealing caps for high-speed applications
    • Caps have a built-in gripper to facilitate removal from the rotor
    • Extra thick walls for durability-resistant to most chemicals
    • Wide mouth design makes filling and decanting easier
    These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity. Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity. Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure. Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.
    centrifuge bottle
    Sterile Centrifuge Bottles 
     
    centrifuge bottle
    Non-sterile Centrifuge Bottles

    Cytology Funnels Category

    BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


     

    metal cytology funnel clip

    Metal Cytology
    Funnel Clips

    Double Cytology Funnels

    Double Cytology Funnels

    Single Cytology Funnels

    Single Cytology Funnels

    Hemodrop Blood Dispenser

    The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.  
    hemodrop
    Hemodrop

    Multipurpose Containers

    These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.

    centrifuge

    Translucent Multipurpose
    Containers

     

    Polypropylene Beakers

    Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).
    centrifuge
    Polypropylene Beaker

    Specimen Collection

    For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit.   
    centrifuge
    Specimen Collection Kit
     

    Tissue & Ultra Tissue Grinders

    We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

    tissue grinder

    Tissue Grinders

    ultra tissue grinder

    Ultra Tissue
    Grinders

    Urine Sedimentation System

    BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

     

    Urine Sedimentation

    Urine Sedimentation
    System