Learnaboutgmp Community

Requirement of HEPA Filters

Dear Members,

Is there any requirement of HEPA filters in Oral Solid Dosage Manufacturing Area (to meet class 100000) as per WHO / USFDA?

1 Like

[quote=vamsemicro]Dear Members,

Is there any requirement of HEPA filters in Oral Solid Dosage Manufacturing Area (to meet class 100000) as per WHO / USFDA?[/quote]

Dear Vamsemicro,
The required degree of air cleanliness in most Oral Solid Dosage manufacturing
facilities can normally be achieved without the use of high-effi ciency particulate air (HEPA) filters, provided the air is not recirculated. Many open
product zones of OSD form facilities are capable of meeting ISO 14644-1
Class 8, “at-rest” condition, measured against particle sizes of 0.5 μm and
5 μm, but cleanliness may not be classifi ed as such by manufacturers.

  1. Where the powders are not highly potent, final filters on a dust
    exhaust system should be fine dust filters with a filter classification of F9
    according to EN779 filter standards.

2)Where harmful substances such as penicillin, hormones, toxic powders
and enzymes are manufactured, the fi nal fi lters on the dust exhaust
system should be HEPA fi lters with at least an H12 classifi cation according
to EN1822 fi lter standards, as appropriate.
3) For exhaust systems where the discharge contaminant is considered
particularly hazardous, it may be necessary to install two banks of HEPA
fi lters in series, to provide additional protection should the first filter fail.
(Reference WHO TRS 937)

This may clear your problem.

Thanks

[quote=vamsemicro]Dear Members,

Is there any requirement of HEPA filters in Oral Solid Dosage Manufacturing Area (to meet class 100000) as per WHO / USFDA?[/quote]

Mr.Vamsee,

I do agree with Shahnawaz.

For Oral dosage forms, with Class 1,00,00 we need to have the HEPA Filters
to maintain the cleanliness level as per ISO 14644.

Even WHO / USFDA proposing the same information through their Training modules on HEPA Filters. So, please go through in the respective websites, for more information.

We need to maintain the safety, purity, identity & quality of product, hence, we need to have the facility of HEPA Filters (controlled environment).

With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

Deal All
There are two basic concepts of air delivery to pharmaceutical production facilities, a recirculation system and a full fresh air system (100% outside air supply).

Recirculation system
8.2.1 There should be no risk of contamination or cross-contamination (including fumes and volatiles) due to recirculation of air.
8.2.2 Depending on the airborne contaminants in the return air system it may usually be acceptable to use recirculated air, provided that HEPA filters are installed in the supply air stream to remove contaminants and thus prevent cross-contamination. The HEPA filters for this application should have an EN1822 classification of H13.
8.2.3 HEPA filters may not be required where the air handling system is serving a single product facility and there is evidence that there is no possibility of cross-contamination.
8.2.4 Recirculation of air from areas where pharmaceutical dust is not generated such as secondary packing, may not require HEPA filters in the system.
8.2.5 HEPA filters may be located in the air handling unit or placed terminally.
8.2.6 Dust from highly toxic processes should never be recirculated to the HVAC system.

Full fresh air systems
A system operating on 100% fresh air and normally typically applies to toxic products where recirculation of air with contaminants is not advised.
(Reference = WHO SUPPLEMENTARY GUIDELINES ON
GOOD MANUFACTURING PRACTICES FOR
HEATING, VENTILATION AND AIR-CONDITIONING (HVAC)
SYSTEMS FOR NON-STERILE DOSAGE FORMS

[quote=vamsemicro]Dear Members,

Is there any requirement of HEPA filters in Oral Solid Dosage Manufacturing Area (to meet class 100000) as per WHO / USFDA?[/quote]

I want the oral tablets, liquids and paste manufacturing unit air handling validation information

Dear Rajkumar,
What would u like to know? please ellaborate your question,

Thanks

HVAC System qualified on risk based analysis, and definitely qualification is the part of validation.

For a pharmaceutical facility, based on a risk assessment, some of
the typical HVAC system parameters that should be qualified may include:
— temperature
— relative humidity
— supply air quantities for all diffusers
— return air or exhaust air quantities
— room air change rates
— room pressures (pressure differentials)
— room airfl ow patterns
— unidirectional fl ow velocities
— containment system velocities
— HEPA fi lter penetration tests
— room particle counts
— room clean-up rates
— microbiological air and surface counts where appropriate
— operation of de-dusting
— warning/alarm systems where applicable.

Ref: WHO TRS 937

Dear Rajkumar

Some of the basic criteria to be considered and include in qualification program however the oral tablets, liquid and paste manufacturing area HVAC requirements are not more strict as in sterile areaqualification but these define below parameter must be considered during qualification:

• air filtration
• air change rate or flushing rate
• room pressure
• location of air terminals and directional airflow
• temperature
• humidity
• outside air conditions

Air filtration and air change rates should ensure that the defined
clean area classification is attained.
The air change rates should be determined by the manufacturer and
designer, taking into account the various critical parameters. Primarily the
air change rate should be set to a level that will achieve the required clean
area classification.
Air change rates normally vary between 6 and 20 air changes per
hour and are normally determined by the following considerations:
level of protection required
• the quality and fi ltration of the supply air
• particulates generated by the manufacturing process
• particulates generated by the operators
• configuration of the room and air supply and extract locations
• sufficient air to achieve containment effect
• sufficient air to cope with the room heat load
• sufficient air to maintain the required room pressure.
Airborne contaminants should be controlled through effective ventilation.
External contaminants should be removed by effective fi ltration of
the supply air.
Directional airfl ow within production or packing areas should assist
in preventing contamination. Airfl ows should be planned in conjunction
with operator locations, so as to minimize contamination of the product by
the operator and also to protect the operator from dust inhalation.
Thanks

Thnaks

Should HVAC be run on UPS for Non-sterile Mfg facility where there is no aseptic operations planned ?

Dear Maheshad

its up to you to keep the electrical back up of non sterile facility on UPS.

But there should be consideration of the cost saving also, a sterile facility is normally kept with the back up load restoration within 60 sec and the sterile area is validated up to 3 min for maintaining the sterility level. So there is no need to keep the non sterile facility on UPS .

Thanks

Ahsan Khan

[quote=Ahsan Khan]Dear Maheshad

its up to you to keep the electrical back up of non sterile facility on UPS.

But there should be consideration of the cost saving also, a sterile facility is normally kept with the back up load restoration within 60 sec and the sterile area is validated up to 3 min for maintaining the sterility level. So there is no need to keep the non sterile facility on UPS .

Thanks

Ahsan Khan[/quote]

yeah , Mr. Ahsan is right, instead of using UPS in non-sterile area you can use generator for regular production if ognaization can be afford, other wise quick change over require as said by Mr. Ahsan

hi, give me datails about class air +1 , +2 , +3 ratio in plant.

thanks,
reddy
msn lab ltd

[quote=guntaka Ramireddy]hi, give me datails about class air +1 , +2 , +3 ratio in plant.

thanks,
reddy
msn lab ltd[/quote]

Plz eloborate your question