4/15/2017 Compressedair

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kiran Gaikwad 1mo Pass your FDA INSPECTIONS! For pharmaceutical,
Asst. Manager QA biologics, medical device, food, cosmetics and
nutraceutical companies regulated by the US FDA. Sha
Compressed air experiences on FDA inspections, FDA Compliance, FDA
GMP, FDA Warning Letters, etc.
Dear sir /madam,
Greetings,
Requested to share regulatory requirement for compressed air specification and testing methodology
to be used in oral solid dosage form.
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Anil Gupta In addition to the Oil Mist test, suggested by Mr Ramesh M. Pednekar, test for
hydrocarbon vapours should also be included.
In general, the PRODUCT CONTACT compressed-air, should comply with standards of Class 1 of
the ISO 8573-1.
The compressed-air quality parameters should be based on risk-analysis.
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Ramtin Ashourzadeh Refer to ISO 7396-1

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Subru Bhat Kiran, There is no FDA guideline for every activity in a pharmaceutical company.
That is why they hire qualified people to think what is best and act accordingly. The bottom
line here is how do you assure the quality of the compressed air that comes in contact with a
drug product. One should be thankful to ISO for coming up with ISO 8573 so you and me can
use it as a guideline as suggested by Ramesh above. Showless
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Voldemars Raimond Karklins Do your impact assessment direct or not or is it just instrument
air? make sure it does not vent into clean rooms even if it is instrument air as then will need to
have full testing as per ISO. Also ensure you actually do have an oil free compressor, surprising
how many "fake" claims are made and also I have had FDA ask for air quality in surrounding
area- paint factories and in one case in an Asian City the site was in a food industry tech park
and the air was full of "cooking oil" particles- extra pre filters needed to pass plus enhance P &
M tasks. Showless
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Vedat Gndemir You can use both the EP 1238 standard and ISO 8573.
Ep 1238 standard is specific to the pharmaceutical industry.
Tests can be done with drager tubes.
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kiran Gaikwad Shall we use pharmacopeial monograph of medicinal air for compressed air for
pharmaceutical use for specification or testing.
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Deepak AV As rightly stated by Subru Bhat on no such guideline from FDA, it is to be done
based on the rationale drawn from the risk assessment for the product in contact with the
quality of air has. However, for an OSD facility you may consider
ISO 8573.1 : 2001 Class 1.2.1
Which equates to
100 Solid Particles 0.1-0.5 micron/m3
1 Solid Particle 0.5 - 1 micron/m3

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4/15/2017 Compressedair
0 Solid Particles 1 - 5 micron/m3
Water Vapour Pressure Dewpoint -40C
Oil aerosol and vapour 0.01 mg/m3.
Showless
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Raja Rao Tulluri Pharmaceutical Process Air & Gas

Infact the pharmaceutical industry does not have a clear-cut guideline or regulation that
specifically addresses compressed air quality specs. Inviteothers
Testing and monitoring of compressed air and other process gases such nitrogen, oxygen,
argon, and carbon dioxide that come into direct contact with pharmaceutical products is vital
to assuring the quality and safety of those products.Compressed air is a Critical Process
Parameter (CPP) whose variability has an impact on the Critical Quality Attribute (CQA) and
therefore should be monitored or controlled to ensure the process produces the desired
quality. [ICH Q8 (R2) II 4.0] During commercial manufacturing, a well-defined system for
process performance and product quality monitoring should be applied to assure performance
within a state of control and to identify improvement areas. [ICH Q10 3.2.1] Quality risk
management should include facilities, equipment, and utilities. Showless
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RAM BABU u can proceed with ISO 8573 for compressed air qualification
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RAM BABU for product contact parts only

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