Product and Services Spotlight: Sample Preparation Device Design and Testing

Sample preparationTest Tubes in medical device design and testing serves as an investigative procedure to assess qualitative and quantitative measures and performances. Safety and quality are the preeminent factors in the medical device manufacturing industry. Stringent regulatory requirements are in place for every phase of a device’s life cycle, including design and testing. OEMs (Original Equipment Manufacturer) and companies that can design and then test medical devices or parts serve a vital role in the medical device industry. However, it’s imperative when looking for companies that can design and then test medical devices or parts demonstrate their quality management processes and practice in all facets of the product lifecycle.

Design Verification and Validation

All manufacturers of any class II and III medical devices, and a number of class I devices, must, by law, establish and maintain design control procedures for the device in order to ensure that specified design requirements are met. Manufacturers are required to establish and maintain such procedures to ensure those design requirements relating to a device are not only appropriate, but address the intended use of the device, that is, meeting the needs of user and patient each. The procedures must include mechanisms for resolving any issues that are incomplete, too ambiguous, or conflict with the regulatory requirements. The procedures must also allow for an adequate evaluation of conformance to the design and reference acceptance criteria essential for the proper functioning of the device. Design verification and validation procedures must also be met to ensure the device will perform as defined, and that the device conforms to user needs and its intended uses.

Testing and Testing Again

All medical devices should be tested in their final product form and condition before being introduced to the market. This is done not only to ensure the quality and safety of the product but to ensure the product’s success in a competitive the marketplace. This includes the evaluation and testing of parts or subcomponents of the device.

To ensure safety, evaluation of medical devices must go beyond design by testing the constituent materials in manufacturing the device. Goals of testing should confirm the safety of individual device materials first, but then, in addition to that, confirm that the steps implemented in manufacturing the device did not compromise the biocompatibility of the device. Factors to consider are all the necessary agents and sterilizers that constitute the manufacturing process. There are a number of lubricants, additives, mold release agents, processing aids, cleaning agents and the like that may compromise the device or part upon contact with it. When looking for a company to manufacture your product be sure that the sample preparation design and testing protocols take these factors into account.

Sample Preparation for the Final Product

Sample preparation of your design should be evaluated in its final product form. In that way, the testing can be designed to incorporate everything involved in making the device. The materials must be safe for patients and the device must be biocompatible with the processes and materials used in the manufacturing process. In sample preparation for most devices, testing of materials should be prepared to mimic expected clinical conditions to determine the potential effects of chemical leachables.

In sum, sample preparation for medical devices is one more important steps in the regulatory process to successfully bring your device to market. Device or part design and testing further establish functional parameters to ensure the product functions as designed and that the end result is the production of high-quality medical devices.

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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

Commode Specimen
Collection Systems

urine container

24 Hour Urine Containers

urine container

24 Hour Urine Containers with Spout

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