HVAC for secondary packaging

Hi, would you consider HVAC system for secondary packaging a direct impact system? I didn’t think so, as it would not affect the product; but the room classification is ISO 8. And in the guideline, one of the criteria for Direct impact system is: “is the system subject to GMP or regulatory requirement or used to demostrate compliance with a registered process?”. Would classifying the room as ISO 8 makes it requiring qualification, or do you think commissioning is enough?

If you specify Class ISO 8 calls for qualification , better not to mention the same.

As the room is specified as ISO Class 8, you do not have any choice but to qualify. Unless you can change the room specs from ISO to Pharma-clean, then no problem.

Hope this is of some help.

I believe requirements should be based on the type of dosage form. If dosage form is liquid , class ISO 8 is not required for secondary packaging.

Even if it is tablet or ampoules, does ISO Class 8 is required? I think “no”, because there is no contact between the product and the enviornment.

The room should be maintained at conditions where the product will be stored. And as a general rule , the room should be clean

The Federal Code of Regulations Section 21 parts 211.42 states:

Any building or buildings used in the manufacture processing, packing, or holding
of a drug product shall be of suitable size, construction and location to facilitate
cleaning, maintenance, and proper operations.

If you look that statement it refers to Airchanges, Dust control, Humidity control, Lighting , Material movements and Temperature control.

Not all products are stable at all temperatures and even during packing humidity must be controlled for some products.
This can be only achieved when the Packing area is atleast Class 100000 or Class 8 in Tropical countries.

I think ISO class 8 is suitable.
The reason is that Temperature and Humidity can be controlled only under Controlled Environments.
Don’t you think you should maintain particular humidity levels when you pack certain Tablets?
In every packing area we check Temp and Humidity Log sheet daily.
If you cannot maintain that there will be operators discomfort will be there.


Secondary area is still a controlled enviroment. Pharmaclean area is preferred, still is this case Temp/Hum, DP, Flow patterns should be done at required interval. Therefore if it’s class 8 one need to do all the tests to ascertain compliance. Only problem i would forsee is that the particle counts might not meet the requirement.

In tropical countries where products are exported to EU/US/UK the packing areas are Class 8. There are multiple regulatory reasons for it.Once any one have Class 8 area they have to comply some requirements.Sale of products in these regions come with a price and also profits.So there are no short cuts.

I heard about a case about Pharmaceutical packing in an Indian company 2 years back. The incident took 6 years back.A popular product was manufactured by an MNC and then sent to Japan. Once such consignment was sent and the entire consignment was rejected . The reason is that in one of the shrink wrappers where product is wrapped in 12 pack containers contained a dead Mosquitoe. There were exchange of words and allegations from both companies. Some of from QA from manufacturing company from India said that mosquitoe had come from Hong Kong port which is one of the route points of this consignment. The company in Japan carried a genotypic analysis of blood clot in the stomach of that Dead Mosquitoe. Its origin was proved from manufactring country.They never gave that company any further consignments. The whole order and contract was cancelled.This is where Quality packing comes.

Dear All,
In general, Secondary packing may done at level 1 protection (General condition)inwhich HVAC sytem equipped with Primary filters only G4 filters,but this is a minmum requirement however, for better compliance, seconadry packing preferably done at ISO Class 8 (at rest position). So, I strongly recommend ISO Class 8 for secondary packing at rest position.

Dear All,

In general, Secondary packing may done at level 01 protection (i.e general condition), inwhich primary filter G4 installed at AHU bank, this is a minimum cGMP requirement. However, for better complaince and considering the risk management, secondary packing should be done in ISO Class 8 (at rest condition).

In exotic nations where items are released to EU/US/UK the packaging places are Category 8. There are several regulating factors for it. Once any one have Category 8 place they have to confirm some specifications. Sale of items in these places come with a cost and also earnings. So, I suggest ISO Class 8 for additional packaging at rest position.