BD Medical - Pharmaceutical Systems:
At Your Service
With over 100 years of expertise in manufacturing and processing technology for parenteral drug delivery systems, BD understands how to best meet the pharmaceutical industry's delivery requirements for injectable medications.
Over the years, we have gained an unrivaled knowledge of the prefill concept: its medical benefits, economic value, marketing advantages, technical aspects, and processing requirements. More than 200 pharmaceutical companies have already chosen BD prefillable systems for their injectable products.
Our experience has led us to develop BD Customer Care, a complete program of services that are available to all of our pharmaceutical customers. The BD Customer Care program has been made possible by the commitment of each of our associates working toward a single goal: to do what is right for our customers.
Click on any of the following to learn more about the breadth of our services:
Worldwide Presence and Coordination
Solutions for end users around the world
Product requirements and end-user expectations differ greatly from one country to another. As parenteral drug delivery specialists, BD Medical - Pharmaceutical Systems continually meets with end users all over the world to learn about their specific needs. Thus, we are able to adapt your product to your regional markets.
Our worldwide investigations have allowed us to clearly identify your varied markets so that we can provide you with pertinent solutions. What's more, our products are registered all over the world and the files can be accessed upon request. This worldwide know-how has been orchestrated so that you may concentrate on your drug.
All over the world
Wherever your company is located, you will find a BD representative who speaks your language, comes from your region and is familiar with your market. Our primary concern is that your needs be understood.
International production used to your advantage
Our four factories – located in France, Mexico, Singapore and the United States – work closely together to satisfy worldwide demand and to maintain the highest level of quality.
Partners in Processing - SCF
Your processing operations reduced to a minimum
We allow you to focus on your core business by delivering our products Sterile, Clean, and/or ready to be Filled. This concept greatly simplifies processing, thus reducing costs for the pharmaceutical company.
Prior to delivery, BD performs all manufacturing and processing, up to and including sterilization. Our manufacturing process meets the stringent demands of the pharmaceutical industry.
Unmatched Production Tools
Continual investment program
BD Medical - Pharmaceutical Systems has implemented a new program to develop and acquire the best machines on the market and to constantly improve their performance. Recent investments include high-technology, environmentally friendly sterilization facilities as well as top quality glass forming, molding and assembly machines.
Triple sourcing
At our factories in France, Mexico and the United States, we produce more than 700 million glass syringes per year.
Products are manufactured in the factory that can best handle your order and, if necessary, we can mobilize all our facilities to follow the evolution of your forecasts. Sophisticated MRP2 planning software is used to manage worldwide demand.
All of our factories are certified ISO 9002.
Technical Support
Partnership with processing equipment suppliers
At BD Medical - Pharmaceutical Systems, we prepare for the evolution of your products by working closely with your technical teams and your machine suppliers. In cooperation with our company, major European and American machine manufacturers develop pharmaceutical processing machines specifically adapted to all of our products.
Machine manufacturers are involved in the early stages of developing each project. This partnership enables us to propose a choice of optimized and updated technical solutions for each product, to comply with your processing requirements.
Specific product development
Should you have specific product requirements, a dedicated project team composed of our experts in marketing, logistics, engineering, quality assurance, regulatory affairs, manufacturing and customer support will evaluate the feasibility, timing and cost of the project, and compliance with international standards.
Product/Process support Should you encounter any technical issues with one of our products before or during processing in your facilities, our Technical Support Team will be ready to assist you. Their wide experience and knowledge of pharmaceutical processing operations can be valuable at any stage of your processing, from the startup phase to routine production.
Elastomer Component Support
BD Medical - Pharmaceutical Systems recommended elastomers
Because the elastomer that contains your drug is critical, BD has validated a wide range of recommended components, including the newest rubber formulations (natural rubber, latex-free).
Because we work closely with our elastomer suppliers, we are familiar with everything the market can offer. Thus, we are in the unique position to advise you on which formulations are best adapted to your drug and to provide you with a complete file of information on them.
Elastomer qualification Each of our recommended elastomers meets the specifications of the American and European pharmacopoeia. Some of them also comply with the Japanese pharmacopoeia. Each formulation is tested by a BD laboratory to ensure it contains no toxic substances, and a study is carried out to determine its general physical properties.
Elastomer validation
A variety of tests approved by our quality assurance and medical directors will allow you to start your stability tests under the best possible conditions.
Once the elastomer has been qualified, it is molded and submitted to stringent testing in real conditions. The assembled syringe is filled and processed, up to and including final sterilization in our autoclave unit. We then proceed with a series of functional tests on breakout and gliding forces, aging, leaking, and ability to be sterilized. You can have access to all these results.
Free access to the world of elastomers
We own a wide variety of molds, to cover nearly all sizes and manufacturers' needs. These molds are available so that your testing can be carried out with the final product. All of this involves no investment on your part.
Regulatory Filing
Drug master files at your disposal
BD has drug master files, 510(k)s and technical dossiers for most of our products. This information complies with national regulatory boards (FDA, and health authorities in Europe, Canada, Australia, Japan...). We can provide you with an English-language copy of the appropriate file, or a letter that grants you access to it. When necessary, BD Medical - Pharmaceutical Systems also assists you in registering your product. Should you encounter some issues in a specific country, we can work directly with the appropriate regulatory board and provide you with documentation and information to facilitate the registration process.
Your guaranteed partner
BD Medical - Pharmaceutical Systems obtained ISO 9002 certification in July 1994. We also comply with the standards established by the FDA, Good Manufacturing Practices, Quality Systems Regulation and EN 46002 for medical devices.
Our Quality Assurance Manual may be reviewed at our headquarters.
Dedicated Customer Quality Assurance
Quality contracts
BD Medical - Pharmaceutical Systems provides you with a complete contract including product drawings and specifications. We also deliver our products with the relevant certificates.
Solutions to your problems
At each of our sites, any customer concern is registered and investigated by a dedicated team, to provide a quick response and corrective action when necessary. By logging every customer complaint, we are able to identify potential problems and, thus, to anticipate them and implement the appropriate intervention.
Facing major changes
BD Medical - Pharmaceutical Systems guarantees that you will be informed of all major product and process changes in writing. We systematically anticipate your questions by providing you with all the necessary information.
Product differentiation and customization
The prefill concept
Prefilled devices differentiate your products, extend their life cycle and provide you with a platform for your sales and marketing strategies. Being both the drug container and injection device, they reduce container overfill, save time for medical staff and minimize hospital and healthcare costs. Furthermore, they increase the levels of safety in the preparation and administration of parenteral drugs, as the transfer of the drug to an injection device is eliminated.
For more product information, please contact us, by email at bdps_marketing@bd.com.
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