How to Create an Easy Transition From the Validation Process to Manufacturing

Medical Injection MoldingOne of the most important phases of a medical product development life cycle is the relationship between your company’s validation expert and the original equipment manufacturer (OEM) of your medical product.

It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the timing of delivery to market, keeping costs within budgeted estimates, and the success of your product.

As a contract manufacturer, at BMP Medical, more than just building medical devices, we build relationships with medical device inventors and innovators. We will work with your validation expert to ensure that validation processes through manufacturing are consistently met to produce devices that meet your company’s specifications as well as being awarded FDA approval.

The FDA requires that validation must provide objective evidence and confirmation through examination that user needs and intended uses as stated are fulfilled. In that regard, as your contract manufacturer, we work with your validation expert hand-in-hand to fulfill this requirement by following standard industry protocols. He or she will have complete knowledge of our OEM medical processes and equipment which makes for an easy transition to manufacturing.

The IQ Protocol
The early stage of process validation, i.e., the installation qualification (IQ) protocol, is critical. Validation methods and criteria are established for your medical device, and also to identify and assess the performance characteristics. For example, this is when we verify that the equipment is correctly installed, any or all instruments are calibrated as needed, and the necessary power supply is met.

The OQ Protocol
The next stage of the process validation, i.e., the operational qualification (OQ) protocol, is to focus on the product risk analysis. OQ is intended to identify and greatly lessen the risk of process failure in large part through statistical modeling, mapping systems and analysis of data collected during the IQ stage.

The PQ Protocol
The next stage of process validation is to perform a number of test runs to verify that your system is operating as expected. The performance qualification (PQ) protocol should be viewed as a pilot production phase that should simulate as much as possible the actual manufacturing conditions of your medical device. The PQ should simulate real-world conditions. Typical tests are up to three production runs (or more if necessary). Statistical modeling can be used to determine the desired yield of the production runs.

Other Areas of Process Validation Consideration
Process validation should consider other real-world conditions such as product packaging and labeling. The ability to anticipate unexpected consequences in packaging design could affect the performance of your product. A prototype delivered or carried in a custom-made case for demonstration is most likely not made of the same components as the packaging material. It is not too uncommon for electrostatic discharge (ESD) failures in electronic medical devices to occur because of packaging material, which is why such packaging should be part of the validation process.

Process validation should also anticipate real-world environmental conditions. Depending on your medical device, simulated temperature fluctuations, humidity levels, shock and vibration stress, or corrosive atmospheres, etc., should be part of the process validation. Unexpected environmental encounters during shipment, handling, and installation most likely will exceed unexpected encounters during actual use. It is best that the validation expert address this issue during the process validation in conjunction with the OEM.

In its decision-making, the FDA relies not only on sound, objective science by medical device inventors and innovators, but a solid foundation for their product development and manufacturing. Process validation is not just an important step, but required by the FDA to receive approval of your medical device. Our role in process validation at BMP Medical is to provide medical device inventors and innovators with the necessary tools to measure the product’s performance with efficiency and accuracy, and to adhere to protocols at all points in the process to ensure an easy transition for FDA approval and the successful commercialization of your device.

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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