微生物分析| Element - yabo88更新,亚慱国际娱乐平台,亚慱体育怎么下载

元件has broad microbiological analysis and detection capabilities for both product validation & lot release protocol. Our experts undertake a wide range of projects for medical device and pharmaceutical manufacturers, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.

微生物分析提供医疗装置，包装，原料或组分的微生物的表征。测试产品的微生物化妆允许制造商确保没有可能伤害用户的细菌或毒素。

与元素合作使贵公司能够减轻风险，知道我们正在努力帮助确保您的成功，并迅速将安全产品带到市场上。有关我们的微生物学分析服务或要求引用的更多信息，今天联系我们。

微生物分析

Bioburden Testing

Prior to final sterilization and packaging, medical devices and pharmaceuticals often must undergo bioburden testing, a quantitative determination of the population of viable micro-organisms either on or in the product. This testing relates to non-sterile medical products as well as pre-sterilization product evaluation. Results from bioburden testing can be utilized to determine proper sterilization levels and procedures.

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Microbial Characterization (ISO 11737-1)

Bioburden testing per ISO 11737 may include aerobic bacteria, spores, aerobic fungi, anaerobes, or any combination of the above. Most commonly, the microbiological analysis involves product extraction followed by a membrane filtration, microbial growth on medium, and enumeration of visible colonies. Alternatively, a plate-count method can also be applied (product specific).

Bioburden Recovery Validation (ISO 11135) – Repetitive or Inoculation Method

Bioburden Recovery验证用于开发和验证产品特异性生物上的测试程序，将评估程序的有效性，评估产品/样品的抗微生物性质，并建立程序的恢复因子。

The repetitive (exhaustive) recovery method uses the naturally occurring bioburden of the product to determine the efficiency of the recovery on a test article.

孢子接种方法通过创造人工生物矿，确定在测试制品上恢复天然存在的Bioburden的效率。

微生物分析

Endotoxin Testing

Testing for endotoxins helps ensure that medical devices and implants are safe for human use. Bacterial endotoxins are known to cause fevers and disease when injected into the bloodstream. It is therefore critical to ensure that these devices are endotoxin-free.

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Kinetic Chromogenic & Turbidimetric Methods (USP 85)

This method is an in-vitro quantitative assay which photometrically detects endotoxins from gram-negative bacteria, using Limulus Amebocyte Lysate (LAL).This microbiological analysis is applicable to medical devices, sterile and nonpyrogenic assemblies, human and animal parenteral drugs, and other biological products as an important predictor of pyrogenic response.

Validation must be performed with each device and change to process/material. Element’s Kinetic Chromogenic detection limit is 0.005 EU/ml, while the Kinetic Turbidimetric detection limit is 0.010 EU/ml.

微生物分析

Cytotoxicity Testing

细胞毒性是对细胞有毒的质量。在监管批准之前，所有医疗器械都需要测试细胞毒素。测试过程是一种快速且高度标准化的方法，可识别生物医学材料或设备中的任何潜在有害物质。yabo娱乐vip结果对于筛选材料是有用的，因为它们是提供生物相容性（无哺乳动物研究）的证据yabo娱乐vip的第一步。

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细胞毒性（ISO 10993-5，USP 87）

ISO 10993-5和USP 87是用于测定与哺乳动物细胞活力相关的医疗装置，组分或原料的毒素的存在。yabo娱乐vip

在最终产品中进行测试，来自最终产品的代表性样品，或以与最终产品相同的方式处理的材料（参见ISO 10993-1）。yabo娱乐vip标本由ISO 10993-12制备。

Any device or implant that is sterilized before use should be sterilized per manufacturer recommendations prior to testing. If non-sterile test samples are used, the lab will also require that they be checked for bacterial contamination in order to avoid a false assessment of cytotoxicity.

Testing is performed in triplicate with L929 cells.

元件does not conduct animal testing.

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