나노입자 기술에 대한 FDA의 가이드 라인

FDA Guidance on Nanotechnology

최근 FDA에서는 정부에 의해 규제되어 지는 제품에 나노 기술을 사용하는 기업에 대한 몇가지 가이드라인을 발표하였습니다.

The FDA issued a number of guidelines for companies using nanotechnology in products regulated by the government. Broadly they issued three guidelines for industry which are based around :

• Whether an FDA regulated product involves the application of Nanotechnolofy
• Safety of Nano materials in cosmetic products
• Assessing the effects of significant manufucturing process changes, including emerging technologies

The general position within these documents is to ask some key questions that will indicate whether a product will be considered to include nanotechnology or not. The criteria include whether the product has material within the nanoscale range (1nm to 100nm) or whether the product is engineered to exhibit unique properties due to its dimensions.

A large part of the FDA work – which mirrors activity in the EU – is driven by concerns about the potential toxicological impact of nanomaterials on the environment. Brendan Casey from FDA presented about the physio-chemical characterisation of extracts of silver nanoparticles containing medical devices. During the talk he emphasised the requirement for improved quantitative tools beyond Dynamic Light Scattering (DLS) that could potentially provide number-based (size) distributions for nanoparticles released into the environment and taken up by living organisms.

The talk covered DLS and how through the use of a known light scattering standard e.g. Toulene, you can get a better understanding on the number of nanoparticles in solution. Additional techniques covered during the talk included linking DLS with a separations device like Field Flow Fractionation (FFF) and other techniques such as Nanoparticle Tracking Analysis (NTA) and Resonant Mass Measurement (RMM).

Nanomaterials have great application potential, however there are certain concerns about the impact that they might have on the environment. This is increasing both the research and regulations that have been implemented within the space. As far back as 2009, ISO issued a standard on critical physio-chemical parameters that should be monitored on nanomaterials and they included:


Dimensions and granulometric distribution

• Shape
• Specific surface area
• Surface charge
• Composition and purity
• Crystalline Structure
• Level of crystallinity
• Coatings and surface composition

관련 응용 자료

( 아래 링크를 클릭 클릭하시면 본문을 다운 받으실 수 있습니다.)
Webinar : A Review of nanomaterial legislation and charaterization methods to meet these challenges.

Application Note : Charaterization of nanoparticle size and state in nanotoxicological and ecotoxicological studes using Nanoparticle Analsis(NTA)

• Case Study : Researchers from the department Envionment et Argo-biotechnologies at the CRP – Gabriel Lippmann in Luxembourg use Nanoparticle Tracking Analysis for toxicology studies.

관련 응용 자료 및 FDA 가이드 자료 신청

– 관련 나노 기술에 대한 FDA 가이드의 전문이 필요하신 분은

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