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GMP News: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

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Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.

http://www.gmp-compliance.org/enews_4409_Endotoxin%20Testing%20Recommendations%20for%20Single-Use%20Intraocular%20Ophthalmic%20Devices_8521,9092,Z-MLM_n.html

 

Related to several outbreaks of Toxic Anterior Segment Syndrome (TASS) in the past, the U.S. Food and Drug Administration and other government and professional organizations started a collaboration to monitor rare eye condition associated with cataract surgery to help industry develop tools for improving safety of eye surgery medical devices. (see FDA News Release December 2011).

Now the FDA published a Draft Guidance for Industry and for Food and Drug Administration Staff on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Because some of the national outbreaks of TASS have been associated with endotoxin, this guidance document was developed to notify manufacturers of the recommended endotoxin limit for the release of intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories in an effort to mitigate future Toxic Anterior Segment Syndrome (TASS) outbreaks. The document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions [510(k)s] for different categories of intraocular devices to aid in the prevention of future outbreaks of TASS.

The recommendations made in this guidance are applicable to devices used within the eye, either as permanent implants or as single-use devices used in intraocular surgery. These include:

A. Intraocular Fluids (21 CFR 886.4275, Class III), including

  • Intraocular fluid (LWL)
  • Viscoelastic surgical aid (LZP)

B. Anterior Segment Solid Devices

1.Intraocular lenses (21 CFR 886.3600, Class III), including

  • Intraocular lenses (HQL)
  • Multifocal intraocular lenses (MFK)
  • Phakic intraocular lenses (MTA)
  • Toric intraocular lenses (MJP)
  • Accommodative intraocular lenses (NAA)
  • Implantable miniature telescope (NCJ)
  • Iris reconstruction lenses (NIZ)

2. Capsular tension ring devices (Class III), including

  • Endocapsular rings (MRJ)

3. Glaucoma devices

  • Aqueous shunts (21 CFR 886.3920, Class II), including
    – Eye valve implant (KYF)
  • Other glaucoma devices (Class III)
    – Intraocular pressure lowering implants (OGO)

4. Phacofragmentation systems (21 CFR 886.4670, Class II), specifically the accessories of irrigation/aspiration sleeves and tubing (HQC)

  • Posterior Segment Solid Devices (Class III)
  • Retinal prostheses (NBF)

Please be aware of the Endotoxin and Pyrogen Testing Conference – Part of PharmaLab 2014 on 19-20 November 2014 in Düsseldorf/Neuss, Germany


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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