Sterility Testing Services
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Manufactured by Assured Bio Labs, LLCbased in USA
Assured Bio provides assistance in complying with the environmental sampling requirements addressed in U.S. Pharmacopeia (USP)Pharmaceutical Compounding—Sterile Preparations. USPapplies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations (CSP) are ...
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based in GERMANY
Apart from the physical measurements we carry out during the performance qualification, we can also provide a direct proof required by several guidelines that the SAL (Sterility Assurance Level) aimed for/required has been reached which enables a correlation to be evaluated between the microbiological kill rate and the predicted ...
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Manufactured by Innovative Health LLCbased in USA
inspection of the reprocessed devices, they are sterilized and quarantined until all sterilization tests are successfully completed. ...
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Manufactured by Noxilizer, Incbased in USA
Noxilizer’s expert in-house microbiology and materials science team will work with you to perform sterilization testing to your requirements. We offer a wide range of testing services that conforms with ISO standards both in-house at our Hanover, MD facility and through external labs. Each customer has a dedicated team working through ...
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Manufactured by Ceutical Labsbased in USA
There are several distinct markets that are served by the Analytical Testing Division. They include Pharmaceutical, Nutraceutical, Medical Device, API (Active Pharmaceutical Ingredient), NDI (New Dietary Ingredient) and Post Sterilization Testing. Two of these categories, API and NDI require additional explanation. Their definitions are as ...
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based in USA
Our development process begins with your idea. The idea can be a rough sketch or a physical prototype. During Concept Development we define the specific requirements for the end product and work with you to refine the design into a functional ...
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Manufactured by ARMI - Advanced Regenerative Manufacturing Institutebased in USA
We offer regulatory consulting services to support our member organizations with preclinical study design, FDA submissions and interactions and clinical trial design to support existing industries and grow new ones. ...
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Manufactured by Plastic Ingenuitybased in USA
Being the best custom thermoformer means having strong capabilities that are matched to the markets we serve. Our in-house structure, coupled with our deep industry expertise and wide geographic footprint, allows us to be the one-stop-shop for all your thermoforming ...
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Manufactured by Puracon GmbHbased in GERMANY
Our pre-validated sterile medical packaging concepts are the right solution for you, if your objective is a fast and standardized ready-to-market solution at low investment ...
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Manufactured by Puracon GmbHbased in GERMANY
Medical devices demand the highest degree of safety, functionality and efficiency. A well planned and performed validation program is the basis for a safe and efficient product and a successful product approval. puracon can support you not only in setting up a product-based validation program, but also in organizing and performing the selected validation program in-house or with expert partners. ...
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Manufactured by Cantel | MEDIVATORS Incbased in NETHERLANDS
Cantel has the ability to manufacture unique products with private labeling and customized packaging. Our products are now marketed by partners in the medical device and filtration industries. Our people and our proven track record make Cantel a reliable and responsive ...
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by Vetterbased in GERMANY
Explore how we transform your API into a supply of high-quality clinical material for your ...
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Manufactured by NextPhase Medical Devices LLC.based in MYANMAR
NextPhase provides comprehensive, integrated contract manufacturing services for finished Class II and III therapeutic and diagnostic medical devices. We have the manufacturing capabilities to ensure quality, speed, and a smooth transition into the ...
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by CZ VACCINESbased in SPAIN
We produce bacterial and viral vaccines under a strict innovative policy to achieve the best ...
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Manufactured by Minaris Regenerative Medicine, LLCbased in USA
Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of ...
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based in USA
The medical device packaging design, testing, and validation process can be intricate and time-consuming, facing intense regulatory scrutiny and often being the largest cause of FDA recalls. Starting medical device packaging validation too late in the design process can create significant challenges for most new product launches. Life ...
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by Biovian Oybased in FINLAND
Adenoviruses are attractive tools for gene therapy, including immuno-oncology, because of their well-defined biology and characteristics including the possibility for large gene inserts. Biovian has proven expertise in adenovirus vector process development, GMP production, and analytics. Since 2004, we have developed processes and have manufactured over 40 clinical adenovirus GMP batches for our ...
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based in USA
to protect the patient from any toxic, physiological, immunogenic or mutagenic effects from the device. This can be achieved with biocompatibility ...
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based in USA
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials and regulatory submissions. Our medical engineering expertise encompasses both ...
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