C10 医药综合 标准查询与下载

ASTM F2315-11 藻酸盐凝胶体中活性细胞或组织的固定或封装的标准指南

The main use is to immobilize, support, or suspend living cells or tissue in a matrix. The use of an encapsulation/immobilization system may protect cells or tissues from immune rejection. When immobilizing biological material in alginate gels, there are numerous parameters that must be controlled. This guide contains a list of these parameters and describes the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of an encapsulation system using alginate. This guide only covers single gelled beads, coated or not, and not double capsules or other constructs. The alginate gelation technology covered by this guide may allow the formulation of cells and tissues into biomedical devices for use as tissue engineered medical products or drug delivery devices. These products may be appropriate for implantation based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

ASTM E2839-11 生产抗菌生物制剂效能评估所用梭状芽胞杆菌的标准试验方法

This test method describes a procedure for preparing a spore suspension of C. difficile strain ATCC 43598 that meets specific criteria necessary for efficacy testing of antimicrobials designed to eliminate C. difficile contamination from environmental surfaces. The acceptability criteria for the spore suspension are: (1) a viability titer of >8 log10/mL, (2) purity of ≥95 %, and (3) that spores be resistant to 10 min of exposure to 2.5 M HCl. 1.1 This test method is for producing C. difficile spores to evaluate antimicrobial formulations for their sporicidal activity. 1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them when appropriate. 1.3 This standard may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Production of Clostridium difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents

ASTM F2103-11 拟用于生物医学和组织工程医疗产品原材料的脱乙酰壳多糖盐的表征和试验标准指南

This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities. The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application. To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS). 1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts. 1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy. 1.4 WarningMercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F2347-11 用于生物医学和组织加固医疗产品应用作为开始材料的透明质酸酶的描述和测试标准指南

This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization of the appropriate hyaluronan for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular hyaluronan. It may have use in the regulation of these devices by appropriate authorities. The hyaluronan covered by this guide may be gelled, cross-linked, extruded, or otherwise formulated into biomedical devices for use in tissue engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These are: identity of hyaluronan, physical and chemical characterization and testing, impurities profile, and performance-related tests.1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan. 1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

ASTM D4774-11 麻醉学中使用者用药物标签的标准规范

The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use. The user may alternatively use black and white labels rather than these colored labels.1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. 1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for User Applied Drug Labels in Anesthesiology

BB/T 0005-2010 气雾剂产品的标示、分类及术语

本标准规定了气雾剂产品的标示要求、分类、术语及其定义。本标准适用于在气雾罐上直接印刷或粘贴的气雾剂产品的标示以及在科研、生产、流通和使用领域的气雾剂产品的分类及术语。

Label, Classification and Terms of Aerosol Products

ASTM E2475-10 与药物制造和控制相关的工艺理解的标准指南

1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts. 1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

ASTM F2315-10 褐藻酸盐胶丸中的活细胞或组织的固定或封包的标准指南

The main use is to immobilize, support, or suspend living cells or tissue in a matrix. The use of an encapsulation/immobilization system may protect cells or tissues from immune rejection. When immobilizing biological material in alginate gels, there are numerous parameters that must be controlled. This guide contains a list of these parameters and describes the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of an encapsulation system using alginate. This guide only covers single gelled beads, coated or not, and not double capsules or other constructs. The alginate gelation technology covered by this guide may allow the formulation of cells and tissues into biomedical devices for use as tissue engineered medical products or drug delivery devices. These products may be appropriate for implantation based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

ASTM E2149-10 测定固定抗菌剂在动态接触条件下的抗菌活性的标准试验方法

The antimicrobial activity of a substrate-bound antimicrobial is dependent upon direct contact of microbes with the active chemical agent. This test determines the antimicrobial activity of treated specimen by shaking samples of surface bound materials in a concentrated bacterial suspension for a one hour contact time or other contact times as specified by the investigator. The suspension is serially diluted both . before and after contact and cultured. The number of viable organisms in the suspension is determined and the percent reduction is calculated based on initial counts or on retrievals from appropriate untreated controls. Note 28212;This method is intended for those surfaces having a percent reduction activity of 50 % to 100 % for the specified contact time.1.1 This test method is designed to evaluate the resistance of non-leaching antimicrobial treated specimens to the growth of microbes under dynamic contact conditions. This dynamic shake flask test was developed for routine quality control and screening tests in order to overcome difficulties in using classical antimicrobial test methods to evaluate substrate-bound antimicrobials. These difficulties include ensuring contact of inoculum to treated surface (as in AATCC 100), flexibility of retrieval at different contact times, use of inappropriately applied static conditions (as in AATCC 147), sensitivity, and reproducibility. This test also allows for the versatility of testing contamination due to such things as hard water, proteins, blood, serum, various chemicals, and other contaminates or physical/chemical stresses or manipulations of the specimens of interest.1.2 Surface antimicrobial activity is determined by comparing results from the test sample to simultaneously run controls.1.3 The presence of a leaching antimicrobial is both pre- and post-determined by the presence of a zone of inhibition.1.4 This test method should be performed only by those trained in microbiological techniques.1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions

ASTM E2656-10 制药用水有机碳总量特征实时发布试验的标准操作规程

Pharmaceutical water is the most common component or ingredient used in pharmaceutical and biopharmaceutical manufacturing. Acceptable purity of the water is important to the quality of the final pharmaceutical product. TOC concentration is a key indicator and attribute of the purity of this water and also an important monitor of the overall performance of the water purification system. TOC analysis is the measurement of all the covalently bound carbon present in the water, not including carbon in the form of carbon dioxide (CO2), bicarbonate icon (HCO3–), or carbonate ion (CO32–), and is reported as the mass of organic carbon per volume. Application of this practice provides pertinent information to make informed decisions on the release of water meeting pharmaceutical TOC concentration specifications. 1.1 This practice establishes an approach to the real-time release testing (RTRT) of pharmaceutical water based on the total organic carbon (TOC) attribute using on-line total organic carbon (OLTOC) instrumentation that is in agreement with current regulatory thinking. 1.2 This practice is harmonized with or supports the concepts of relevant ASTM International Committee E55 on Manufacture of Pharmaceutical Products standards, ICH Harmonized Tripartite Guidelines, the US FDA PAT Guidance, and US FDA Pharmaceutical cGMPs. 1.3 This practice does not provide general guidance information for pharmaceutical procedures that are considered standard practice in the pharmaceutical industry. This practice provides specific guidance for non-standardized procedures. 1.4 This practice does not address the user’s various internal procedures for risk, change, or quality management systems. The overall project effort associated with this practice shall be proportional to the overall risk of failing the pharmaceutical water’s TOC concentration specification. 1.5 This practice does not purport to establish how to comply with pharmacopeias. The RTRT methodology selected must assure compliance with the user’s current required pharmacopeias. However, compliance with pharmacopeia TOC methods is not necessarily sufficient to meet current regulatory expectations for RTRT. 1.6 This practice does not purport to substitute for or replace compendial bioburden testing requirements. It is strictly applicable to the TOC attribute of water quality. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

ASTM F2259-10 质子核磁共振波谱法测定褐藻酸盐中的化学成分和序列的标准试验方法

The composition and sequential structure of alginate determines the functionality of alginate in an application. For instance, the gelling properties of an alginate are highly dependent upon the monomer composition and sequential structure of the polymer. Gel strength will depend upon the guluronic acid content (FG) and also the average number of consecutive guluronate moieties in G-block structures (NG>1). Chemical composition and sequential structure of alginate can be determined by 1H- and 13C-nuclear magnetic resonance spectroscopy (NMR). A general description of NMR can be found in <761> of the USP24-NF19. The NMR methodology and assignments are based on data published by Grasdalen et al. (1979, 1981, 1983). , , The NMR technique has made it possible to determine the monad frequencies FM (fraction of mannuronate units) and FG (fraction of guluronate units), the four nearest neighboring (diad) frequencies FGG, FMG, FGM, FMM, and the eight next nearest neighboring (triad) frequencies FGGG, FGGM, FMGG, FMGM, FMMM, FMMG, FGMM, FGMG. Knowledge of these frequencies enables number averages of block lengths to be calculated. NG is the number average length of G-blocks, and NG>1 is the number average length of G-blocks from which singlets (-MGM-) have been excluded. Similarly, NM is the number average length of M-blocks, and NM>1 is the number average length of M-blocks from which singlets (-GMG-) have been excluded. 13C NMR must be used to determine the M-centered triads and NM>1. This test method describes only the 1H NMR analysis of alginate. Alginate can be well characterized by determining FG and NG>1. In order to obtain well-resolved NMR spectra, it is necessary to reduce the viscosity and increase the mobility of the molecules by depolymerization of alginate to a degree of polymerization of about 20 to 50. Acid hydrolysis is used to depolymerize the alginate samples. Freeze-drying, followed by dissolution in 99 % D2O, and another freeze-drying before dissolution in 99.9 % D2O yields samples with low 1H2O content. TTHA is used as a chelator to prevent traces of divalent cations to interact with alginate. While TTHA is a more effective chelator, other agents such as EDTA and citrate may be used. Such interactions may lead to line broadening and selective loss of signal intensity. Samples are analyzed at a temperature of 80 ± 1°C. Elevated sample temperature contributes to reducing sample viscosity and repositions the proton signal of residual water to an area outside that of interest.1.1 This test method covers the determination of the composition and monomer sequence of alginate intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of alginate has been published as Guide F2064. 1.2 Alginate, a linear polymer composed of β-D-mannuronate (M) and its C-5 epimer α-L-guluronate (G) linked by β-(1>4) glycosidic bonds, is characterized by calculating parameters such as mannuronate/guluronate (M/G) ratio, guluronic acid content (G-content), and average length of blocks of consecutive G monomers (that is, NG>1

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy

KS P 1308-2009 造瘘术设备术语

이 표준은 스토마 보유자를 위해 스토마 기기에 관한 주요 용어와 그 정의에 대하여 규정한다

Glossary of terms used in ostomy aids

SANS 5550:2009 抗生素药效.微生物琼脂扩散化验法(2点法)

Specifies a microbiological method for the determination of the potency of various antibiotics in pharmaceutical and other products by means of an agar diffusion two-point assay technique.

Potency of antibiotics - Microbiological agar diffusion method of assay (two-point technique)

NF S98-004-3:2009 卫生保健产品的消毒.生物指示剂.第3部分:湿热消毒工方法的生物指示剂

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes.

NF S98-001-1:2009 卫生保健产品的消毒.化学指示剂.第1部分:一般要求

Sterilization of health care products - Chemical indicators - Part 1 : general requirements.

NF S98-004-2:2009 卫生保健产品的消毒.生物指示剂.第2部分:环氧乙烷消毒方法的生物指示剂

Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes.

SANS 599:2009 无菌氯化钠和右旋糖静脉输液

Covers chemical and biological requirements for a solution of sodium chloride and dextrose in water for injections that has been dispensed into suitable containers, sealed and sterilized. It also specifies the required marking.

Sterilized sodium chloride and dextrose intravenous infusion

GOST R 52249-2009 医药产品用优良制造规范(GMP)

Good manufacturing practice for medicinal products (GMP)

ASTM F2224-09 医用高纯水合硫酸钙或二水硫酸钙规范

1.1 This specification covers material requirements for unfabricated and fabricated forms of hydrated calcium sulfate intended for surgical implants. Fabricated forms may include pressed and cast surgical implants in various geometric shapes. The calcium sulfate hemihydrate in the unfabricated form can be converted with the addition of water or other water-containing solutions to a fabricated calcium sulfate dihydrate form. 1.2 The requirements of this specification apply to calcium sulfate combined with two molecules of water or two calcium sulfate molecules sharing one water molecule.Approximate chemical formulae: Calcium Sulfate Dihydrate CaSO4·2H2O Calcium Sulfate Hemihydrate CaSO4·1/2H2O or CaSO4·H2O·CaSO4 1.3 This specification specifically excludes calcium sulfate anhydrite and calcium sulfate forms that contain additives such as reinforcing phases, medicaments, biological agents, and so forth. 1.4 The presence of processing aids does not exclude a product from the physical and mechanical requirements of this specification. 1.5 Some provisions of Specification C 59/C 59M and Test Methods C 472 apply. Special requirements that are detailed in this specification are included to characterize the material which will be used in surgical implants. 1.6 The biological response to calcium sulfate in bone tissue has been well characterized by a history of clinical use (1-14) and by laboratory studies (15-18). 1.7 The following precautionary caveat pertains only to the test method portion, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

ANSI/AAMI/ISO 13959:2009 血液透析和相关治疗用水

Specifies specifies minimum requirements for water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and for the reprocessing of haemodialysers. Does not address the operation of water treatment equipment nor the final mixing of treated water with concentrates to produce the dialysis fluids used in such therapies. That operation is the sole responsibility of dialysis professionals. Does not apply to dialysis fluid regenerating systems.

Water for hemodialysis and related therapies