Operational Excellence and Process Improvement
How BD can improve the development of your combination product
- Process Improvement
- Process Improvement at Work
- Advance Your Drug to Market
Helping Develop Your Combination Product
BD is one of the top 5 medical technology companies in the world. For over 125 years, BD has been supplying medical devices to the healthcare industry and today we produce over 37 billion products annually.1 BD Medical – Pharmaceutical Systems is part of the BD Medical Segment. With over 60 years experience in the pharma industry, we are the market leader in prefillable syringes.
One important element of delivering high quality prefillable syringes for combination drug products is around processability. The processability of product components impacts the quality, end cost and the ability to scale-up production.2
We can illustrate the benefits of component processability improvement, with a simple case study.
Plunger stoppers must enable the safe delivery of complex biological drugs, while ensuring regulatory compliance.
The BD SCF™ PremiumCoat®* 1mlL plunger stopper was developed for the delivery of biologics.
BD and the machine maker Bausch+Ströbel evaluated the manufacturing process of the BD SCF™ PremiumCoat®* plunger stopper on Bausch+Ströbel manufacturing lines to determine:
- Characteristics of the plunger stopper
- Processability on Bausch+Ströbel machines using market standard format parts
- Process reliability
- Functional performance of manufacturing lines during filling and assembly
Every step of stopper processing on the manufacturing line was tested, including plunger sorting, feeding, insertion and assembly.
We found that BD SCF™ PremiumCoat®* tests support processability performance on Bausch+Ströbel manufacturing lines with results indicating:
- The BD SCF™ PremiumCoat®* Plunger Stopper is designed to require less force for assembly when using a vent tube and generate lower temperatures and reduced glide force†‡ during production§‡3
- The BD SCF™ PremiumCoat®* Plunger Stopper can be assembled using either vent tube or vacuum technology with a reduction of detectable wrinkles‡3
This means that the Bausch+Ströbel machines, which are designed for processing the current market alternative stopper, could be used for the BD SCF™ PremiumCoat® plunger stopper. This also means that a full retrofitting of existing machines is not required to complete filling and assembly using the BD SCF™ PremiumCoat® plunger stopper.
BD Operational Excellence and Process Improvement Functions
Applying advanced technology creates value for your investment
The experts at BD have deep industry experience in a wide range of aspects of medical technology, innovation, development and manufacture, and aim to produce a high-quality product. Applying our advanced technology and expertise to the development of your combination product can create value for your investment.
Drug Delivery Systems
- Material selection and characterization
- System performance of combination product optimization
- Compatibility with drug from mechanical and chemical standpoint
- Co-development partnering for customization and prototyping
Manufacturing Expertise & Processes
- Extensive manufacturing knowledge and reliable supply chain system
- High-capacity production
- Safety stock
- Dual sourcing of major components
- Extensive network of supplier relationships
- Relationships with regulatory experts
- Ability to minimize impact of unexpected events
- A harmonized quality assurance system
- Global and harmonized manufacturing process meets stringent standards
Advance Your Drug to Market With BD Operational Excellence and Process Improvement
Your partner for operation excellence, drug stability, optimized drug containment and product protection
At BD we understand the importance of bringing your product to market in the shortest time possible.
BD offers fully integrated, innovative drug delivery systems, helping to accelerate our customer time to market, for quick access to combination products for patients.
As the pharmaceutical landscape continues to evolve, manufacturers must prioritize both product quality and operational efficiency.
This means that the need for operational excellence has never been more crucial. Process improvement is the driving force behind the pursuit of operational excellence, as businesses strive to meet customer expectations and out-maneuver competitors.
Our experts will work with you to improve your combination product development processes and to help ensure operational excellence.
We Optimize
- Manufacturing line and processes
- Filling and assembly equipment for BD products
- Process capability to reduce variability and defects
We Conduct
- Feasibility testing on your individual application
- Root cause analysis and post-approval change management
We Offer
- Quality specifications and Human Factors Engineering support
- Equipment rental for low volume assembly
- Training to optimize the manufacturing proces
With system inspection and improvement to increase product development and manufacturing efficiency, we can potentially elicit savings.
With an increased focus on performance of our products in fill and finish operations, we help meet filling capacity demands and cost pressures.
With a holistic approach we address efficiency challenges such as:
-
Debagging
Single Header Bag(SHB)/Double Header Bag (DHB) folding
-
Delidding
Tyvek® packaging corners
-
Conveying
Tub and barrel
-
Filling
Bent nest
Explore our products
Prefillable syringe systems
BD is uniquely positioned to offer prefillable syringe systems with expertise in drug container interactions, primary container selection and container/device integration for various drug therapies.
Safety and shielding systems
BD offers a wide range of safety and shielding systems that feature innovative needle shielding system technology for your injectable drug.
Self injection systems
BD partners with you to develop self injection systems that enable drug administration across a range of volumes and viscosities, leveraging BD primary container technologies and expertise with a focus on reaching the market faster.
Plunger Stoppers
With our two stopper processing sites, we aim to offer security of supply and business continuity for your drug combination product needs.
Backstops and plunger rods
As part of our integrated approach to help you develop drug combination products, we offer BD Backstops and BD Plunger Rods in a range of sizes, materials and colors.
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Prefillable syringe systems
Safety and shielding systems
Self injection systems
Plunger Stoppers
Backstops and plunger rods
*PremiumCoat is a registered trademark of Aptar Pharma, Inc.
FluroTec is a registered trademark of West Pharmaceutical Services, Inc.
† Glide force for PremiumCoat stopper was measured at: 10.08N while the glide force peak reached with the BD FluroTec® Plunger Stopper 21.09N.
‡ When compared to the BD SCF™ FluroTec™∞ Plunger Stopper.
§ The glide force measured during Bausch + Ströbel processability tests was done in insertion tube | Alternative stopper tested is FluroTec®∞ 1mlL.
- BD Annual report 2023
- https://www.sciencedirect.com/topics/engineering/processability
- Becton, Dickinson and Company. Bausch + Ströbel SCF™ PremiumCoat® Plunger Stopper: Proof of processability. BD Medical – Pharmaceutical Systems; 2020 V-630076 2020.