Biomedical product standards

For a wider acceptance, conformance to internationally accepted practices and standards is desired. These requirements are rigorous, entailing chitin and chitosan materials and their products to have been produced under some form of Good Manufacturing Practice (GMP) process and evaluated under Good Laboratory Practice (GLP) procedures. Featured next, by no means exhaustive, are four of the better known examples. Collectively, they demonstrate that chitin and chitosan biomedical products conforming to the present international regulatory requirements can be attained. 

First, there remains a continuing need for standardized chitin and chitosan materials to be readily available for pnrchase at reasonable costs. This is advocated as one channel that can eliminate the persistent ambignity of the purity, degree of acetylation/deacetylation, molecular weight, and other standard properties found in the scientific literatnre for this biopolymer. The proliferation of chitin and chitosan in biomedical research and eventnally biomedical products demands that this take place. 

One of the most important inputs for the project development of a biomedical product is the analysis of applicable regulatory standards. Where there are nationally or internationally recognized reference standards, the definition of the requirements of a biomedical product is facilitated. 

A standard is recognized if it is issued and validated by an institution whose authority shall be recognized. The authorities involved in the processing and issuance of a standard in the context of biomedical products are certainly to be considered ... 

Proper risk management implementation is critical in the development and production of a biomedical product. ISO 14971 is an internationally recognized standard used for... 

Models and reference standards applicable to design and production of biomedical products... 

In this section, we give a very general and synthetic view of the reference standards involved into the design and implementation of management systems dedicated to development and production of biomedical products, with reference to the main European and US standards. 

The procedures for the market release of biomedical products involve aspects of the management system as well as product conformity, eg. Annex V and Annex II of Directive 93/42/EEC speak expUcitly of system requirements the same is for good manufacturing practice (GMP) standards both EudraLex and FDA 21 CFR 211 contain requirements for a quality system. 

Various novel applications in biotechnology, biomedical engineering, information industry, and microelectronics involve the use of polymeric microspheres with controlled size and surface properties [1-31. Traditionally, the polymer microspheres larger than 100 /urn with a certain size distribution have been produced by the suspension polymerization process, where the monomer droplets are broken into micron-size in the existence of a stabilizer and are subsequently polymerized within a continuous medium by using an oil-soluble initiator. Suspension polymerization is usually preferred for the production of polymeric particles in the size range of 50-1000 /Ltm. But, there is a wide size distribution in the product due to the inherent size distribution of the mechanical homogenization and due to the coalescence problem. The size distribution is measured with the standard deviation or the coefficient of variation (CV) and the suspension polymerization provides polymeric microspheres with CVs varying from 15-30%. 

Part—I has three chapters that exclusively deal with General Aspects of pharmaceutical analysis. Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management. Critical information with regard to description of the finished product, sampling procedures, bioavailability, identification tests, physical constants and miscellaneous characteristics, such as ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as urea, bilirubin, cholesterol and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes... 

Some new materials perspective for advanced biomedical technologies, especially carbon nanoparticles like fullerenes, are potentially mutagenic, carcinogenic and immunogenic [16,65], Therefore, standard tests of the morphological transformation of Syrian hamster embryonic cells in cultures on these materials (described in detail by [68,69]) can be performed. Immune activation of bone and vascular cells on the materials can be estimated by increased concentration of immunoglobulin and selectin adhesion molecules (ICAM-1, VCAM-1, ELAM-1), which bind cells of the immune system [15,16,18,19,23], as well as by the production of cytokines, such as tumor necrosis factor alpha or interleukins beta [55],... 

The GCP guidelines have not always been fully applied to other biomedical research, such as some independent studies on marketed products initiated by clinicians without support from the manufacturer. The training that clinicians, scientists and technicians receive from company-based staff before and during a sponsored clinical trial adds considerably to the quality standards. 

This review describes currently useful methods for the separation and characterization of inorganic complexes. Some separations are required just to remove unreacted reagents or minor side products. Advances for these standard techniques (ion chromatography, normal and reversed-phase chromatography, thin-layer methods) are often limited by the availability of a specialized support material. However, newer, innovative methods for the separation of species have evolved, particularly separation methods needed in biomedical and industrial applications. 

Unfortunately, the GCP guidelines are not always applied to other biomedical research and rarely to independent studies on marketed products initiated by clinicians without support from the manufacturer. There is still a double standard in therapeutic research and therefore in published papers arising from them. Editors and reviewers do not see the full documentation of non-sponsored biomedical research, whereas the regulatory authorities and their expert advisers will expect to see all data in the support of new medicines. The extent of the differences in standards is recognised when a potential investigating site is visited and one realises that there are no SOPs, that documentation of laboratory procedures is suboptimal and that staff are not properly trained. These facets are mentioned because the training that clinicians, scientists and technicians receive from company-based staff before and during a sponsored clinical trial adds considerably to the quality standards. 

Requirements for biomedical pxslymer production and processing besides the strict control on biomedical polymer itself, matters harmful to human body shall also be prevented during material pa-oduction the purity of the raw materials used in biomedical polymer synthesis shall be strictly controlled, no harmful matter is allowed and the content of heavy mental shall be within the limit additive processing shall meet medical standard the production environment should meet proper standard for cleanliness. 

In vitro and in vivo biocompatibUity tests are required by government agencies for drug delivery system and biomedical device approval [16]. In vitro dissolution testing is used to assess in vivo performance and is important during formulation development as weU as for product quality assurance. Standardized dissolution methods are under development for novel polymeric formulations such as microspheres, nanoparticles, and in situ forming gels [17]. 

ASTM. F2103-01 Standard guide for characterization and testing of chitosan salts as starting materials intended Iot use in biomedical and tissue-engineered medical product applications (2001)... 

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