Graver的技术管理医疗保健应用中的污染物风险,例如医疗器械、化妆品、诊断和药剂。
医疗保健行业由多种应用组成,包括医疗器械、化妆品、诊断试剂、生物制药以及用于生产外用药、口服药和肠胃外用药的成分。随着人口的增加以及慢性和新型疾病的增加,先进的药物、药物和治疗的开发对于维护发达国家和发展中国家人口的健康和安全至关重要。这些高度监管的应用需要高纯度标准以及高度可控的过程和环境,以有效管理颗粒、微生物污染物和溶解材料的风险,这些颗粒物、微生物污染物和溶解材料源自制造过程,否则如果不去除,则会对健康造成危害。通过采取适当的预防措施来管理人员、流程和材料,将有助于在遵守法定法规的同时保持高质量的标准。
100 多年来,Graver Technologies 一直在设计和生产卓越的过滤、分离和净化解决方案。无论是生产公用空气、诊断药物、抗生素还是疫苗,Graver Technologies都有市场解决方案。我们广泛的产品提供了一种具有成本效益的流程,可生产出始终如一、高质量的产品,以满足应用中的性能、安全和监管要求。目前正在开发的许多医疗保健产品将通过多步合成工艺生产,需要大量的下游纯化。Graver Technologies的产品范围包括预过滤器、抛光过滤器、微生物浓度、消毒级过滤器、微滤和超滤管状横流过滤器以及专有的吸附剂技术,确保医疗保健行业产品的制造安全且不受污染。
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Some of our the standard Certifications and Compliance Standards: ASME Code, Section XI, Division I Compliance, PED 97/23/EC Compliance, ISO 9001:2015 Certification, NSF 61 Certification, FDA Title 21 Compliance, USP Class VI Compliance, EU 1935 OML Compliance
Ultrapure water (UPW), high-purity water (HPW) is water that has been purified to stringent specifications which may include microbial, particulate, and metal contaminants. The standards of water quality will vary significantly by application and industry. For healthcare applications, the USP (United States Pharmacopeia) has 8 different classifications, with the common classification for processing high purity water being Water for Injection (WFI) and Purified Water.
Microfiltration technology is not effective in removing chlorine and fluorides in water. These are typically removed through use of carbon based adsorbent technology.
Medical devices can use a wide range of filter technologies. Graver focuses specifically upon use of PLEKX® technology for the removal and/or reduction of multiple odor, gas, fume and chemical contaminants in both doctors' offices and surgical suites.
Several essential applications for filters. Tank vent or fermentation feed air filters, the choice of which depends upon the specific method being used in the fermentation process, ensure that particles and microbes do not enter the process through air sources. These filters should utilize a hydrophobic membrane such as PTFE and have claims for sterility. A second area is to ensure that all fluids in the process are microbial-free, so filtration using a 0.2 micron hydrophilic membrane filter that is rated as sterilizing grade is commonly used. This would apply to water, nutrient broths or any liquid additive essential to the process.
Generally, HEPA filters are not intended to be washed and reused.
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