Group Admins
Cleanroom Standards
Public Group active 11 months, 1 week agoUSP 797, BioPharmaceutical, EUGGMP, I.E.S.T., I.S.O., ASTM F1670, ASTM F1671, Federal, Pharmaceutical, FDA
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Bill Johnson posted on the forum topic Standard for hospital? in the group Cleanroom Standards: 1 year ago · View
If I was the one being operated on in the OR I would want to have a laminar flow cleanroom area Class 1/ISO Class 3. I would want all air HEPA filtered and I would also want to UV treatment of all airflow. Unforunately most of the OR rooms I have seen have an air [...]
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Bill Johnson joined the group Cleanroom Standards 1 year ago · View
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mike zines joined the group Cleanroom Standards 1 year, 1 month ago · View
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Lauren posted an update in the group Cleanroom Standards: 1 year, 2 months ago · View
The IEST is inviting cleanroom professionals to weigh in on the draft version of the updates to ISO/DIS 14644-1—Part 1: Classification of air cleanliness by particle concentration and ISO/DIS 14644-2—Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1, which were updated last December.
Those affected by the changes can leave comments until April 15th, 2011, by going here http://www.iest.org/i4a/forms/form.cfm?id=67
Access to the peer-reviewed standards are here http://www.iest.org/i4a/pages/index.cfm?pageID=3986
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Lauren joined the group Cleanroom Standards 1 year, 2 months ago · View
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Angel M Martinez joined the group Cleanroom Standards 1 year, 2 months ago · View
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Angel M Martinez joined the group Cleanroom Standards 1 year, 2 months ago · View
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Angel M Martinez joined the group Cleanroom Standards 1 year, 2 months ago · View
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Sophie Phipps posted an update in the group Cleanroom Standards: 1 year, 2 months ago · View
BSI (British Standards Institution) is holding a free UK event on the forthcoming standards for cleanrooms, in March.
If you’d like to attend the consultation on ISO 14644 then visit BSI’s website to reserve a place. It’s a great way to get the inside track on the standards as well as meeting industry experts, and network with your peers.
You can find out all about it and register at: http://shop.bsigroup.com/cleanroomsevent
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Sophie Phipps joined the group Cleanroom Standards 1 year, 2 months ago · View
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admin posted an update in the group Cleanroom Standards: 1 year, 3 months ago · View
Straightforward info on USP 797 can be found here
http://gsfcc.org/index.php?title=10_Simple_Ways_to_Fast_Track_to_USP_797_Compliance
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Brad joined the group Cleanroom Standards 1 year, 4 months ago · View
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Howard Siegerman posted on the forum topic FDA In spection in the group Cleanroom Standards: 1 year, 7 months ago · View
Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.Regards
Howard -
Howard Siegerman posted on the forum topic FDA In spection in the group Cleanroom Standards: 1 year, 7 months ago · View
Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.Regards
Howard -
Howard Siegerman posted on the forum topic FDA In spection in the group Cleanroom Standards: 1 year, 7 months ago · View
Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.Regards
Howard -
Howard Siegerman posted on the forum topic FDA In spection in the group Cleanroom Standards: 1 year, 7 months ago · View
To my knowledge, only companies involved in FDA-regulated industries, INCLUDING BUT NOT LIMITED TO the manufacture of pharmaceuticals, biotechnology products and medical devices, are subject to FDA inspections. I believe that a company does not call the FDA and request an FDA inspection; the FDA tells you when they are coming. Furthermore, the inspection goes [...]
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douglashay joined the group Cleanroom Standards 1 year, 12 months ago · View
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sleale joined the group Cleanroom Standards 2 years ago · View
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cyclic joined the group Cleanroom Standards 2 years, 1 month ago · View
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hodess joined the group Cleanroom Standards 2 years, 2 months ago · View
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