environmentalmonitoring2011.blogspot.com

Environmental Monitoring

Wednesday, May 4, 2011. Follow up activities after EM. EM excursions higher than or equal to Alert levels are out of specifications (OOS). OOS results should be documented in deviation reports. Deviation reports usually include the site of the excursion, its result(s), microbial ID results, manufacturing department’s response (cleaning activities of the room for example), and the next consecutive sample’s result. Corrective Action/ Preventative Action (CAPA). Tuesday, May 3, 2011. Alert and Action levels.

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Environmental Monitoring | environmentalmonitoring2011.blogspot.com Reviews

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Wednesday, May 4, 2011. Follow up activities after EM. EM excursions higher than or equal to Alert levels are out of specifications (OOS). OOS results should be documented in deviation reports. Deviation reports usually include the site of the excursion, its result(s), microbial ID results, manufacturing department’s response (cleaning activities of the room for example), and the next consecutive sample’s result. Corrective Action/ Preventative Action (CAPA). Tuesday, May 3, 2011. Alert and Action levels.

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Environmental Monitoring | environmentalmonitoring2011.blogspot.com Reviews

https://environmentalmonitoring2011.blogspot.com

Wednesday, May 4, 2011. Follow up activities after EM. EM excursions higher than or equal to Alert levels are out of specifications (OOS). OOS results should be documented in deviation reports. Deviation reports usually include the site of the excursion, its result(s), microbial ID results, manufacturing department’s response (cleaning activities of the room for example), and the next consecutive sample’s result. Corrective Action/ Preventative Action (CAPA). Tuesday, May 3, 2011. Alert and Action levels.

INTERNAL PAGES

environmentalmonitoring2011.blogspot.com

1

Environmental Monitoring: January 2011

http://environmentalmonitoring2011.blogspot.com/2011_01_01_archive.html

Monday, January 31, 2011. Environmental Monitoring or EM is a practice used in GMP pharmaceutical (and some medical device) manufacturing facilities throughout the world. Basically, an EM technician (usually a microbiologist), performs viable air, viable surface, and non viable particle monitoring activities in production clean rooms. Subscribe to: Posts (Atom). View my complete profile. Picture Window template. Powered by Blogger.

2

Environmental Monitoring: Deviation/Investigations/CAPAs

http://environmentalmonitoring2011.blogspot.com/2011/05/deviationinvestigationscapas.html

Wednesday, May 4, 2011. Follow up activities after EM. EM excursions higher than or equal to Alert levels are out of specifications (OOS). OOS results should be documented in deviation reports. Deviation reports usually include the site of the excursion, its result(s), microbial ID results, manufacturing department’s response (cleaning activities of the room for example), and the next consecutive sample’s result. Corrective Action/ Preventative Action (CAPA). Subscribe to: Post Comments (Atom).

3

Environmental Monitoring: Environmental monitoring...why do we need to do so?

http://environmentalmonitoring2011.blogspot.com/2011/02/environmental-monitoringwhy-do-we-need.html

Monday, February 7, 2011. Environmental monitoring.why do we need to do so? According to FDA 21 CFR part 211.113, "Control of Microbial Contamination", it says " appropriate written. Designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed" and ". Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed". Manufacturing facilities must...

4

Environmental Monitoring: Environmental Monitoring Equipment

http://environmentalmonitoring2011.blogspot.com/2011/04/environmental-monitoring-equipment.html

Tuesday, April 26, 2011. Environmental Monitoring Equipment in Sterile Bio-Pharmaceutical Manufacturing Facilities. According to 21 CFR 211.42, cGMP for Finished Pharmaceuticals-Design and Construction Features. On my next blog, I will talk about determining alert and action levels of manufacturing rooms. 21 CFR 211.42, “Design and construction features”. Http:/ www.sterile.com/pages/products/environmental/sma-atrium.htm. Http:/ www.cerhb.ufl.edu/pdf/edcenter/environmental monitoring.pdf.

5

Environmental Monitoring: Environmental Monitoring Alert/Action levels.

http://environmentalmonitoring2011.blogspot.com/2011/05/environmental-monitoring-alertaction.html

Tuesday, May 3, 2011. Environmental Monitoring Alert/Action levels. Alert and Action levels. Action Level Alert Level. US Fed Std 209E EU Grade ISO 14644-1 ≥ 0.5 µm particles/ft3 ≥ 0.5 µm particles/m3 ≥ 0.5 µm particles/ft3 ≥ 0.5 µm particles/m3. Class 100 A Class 5 100 3,500 80 2800. Class 10,000 C Class 7 10,000 350,000 7000 245,000. Class 100,000 D Class 8 100,000 3,500,000 40,000 1,400,000. Table 1: Non viable particulate air Alert/Action levels. Viable air Action level. Class 100 A Class 5 1 5.

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environmentalmonitoring2011.blogspot.com

Environmental Monitoring

Wednesday, May 4, 2011. Follow up activities after EM. EM excursions higher than or equal to Alert levels are out of specifications (OOS). OOS results should be documented in deviation reports. Deviation reports usually include the site of the excursion, its result(s), microbial ID results, manufacturing department’s response (cleaning activities of the room for example), and the next consecutive sample’s result. Corrective Action/ Preventative Action (CAPA). Tuesday, May 3, 2011. Alert and Action levels.

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