Containers

Sterility

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What paragraph (c) requires Three requirements in one sentence Our answer to the first is reasonable Our answer to the second is nothing And our answer to the third is nothing Which is a hard stop rather than a limitation Sterilizing in house is a separate undertaking Temperature range is published and is not that So read (c) as the gate for this catalog Clean is also a shipping question And case pack matters for that reason Stated plainly because the alternative is dangerous References

No sterile container in this catalog. None, anywhere.

What paragraph (c) requires

Containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties, and such depyrogenation processes shall be validated.

Three requirements in one sentence

Clean, always. Sterilized, where the nature of the drug indicates it. Depyrogenated, likewise, and with the process validated.

Our answer to the first is reasonable

These are new containers supplied in cases, and clean is the ordinary condition of a new molded or formed container.

Our answer to the second is nothing

Checked catalog-wide: no container or closure in this catalog is supplied sterile. Not on this shelf and not anywhere.

And our answer to the third is nothing

No depyrogenation, no pyrogen data, and no validated process of any kind on our side.

Which is a hard stop rather than a limitation

If the nature of the preparation indicates a sterile container, this catalog is not where it comes from. There is no workaround on our shelf.

Sterilizing in house is a separate undertaking

With its own validation requirement under the same paragraph, and nothing about our containers is qualified for it. We publish no autoclave tolerance.

Temperature range is published and is not that

410 of 486 rows carry one, and a storage and use temperature range is not a statement about autoclave or dry heat cycles.

So read (c) as the gate for this catalog

Non-sterile preparations, and the jars and bottles here are a reasonable starting point. Sterile preparations, and they are not.

Clean is also a shipping question

A container is clean when it leaves the molder and it travels in a case through a warehouse. Whether it arrives clean enough is something a compounder inspects rather than something a catalog certifies.

And case pack matters for that reason

Case pack is published on 482 of the 486 rows here. A case opened once and used down is handled less than a case opened and left standing.

Stated plainly because the alternative is dangerous

A compounder who assumes a packaging supplier has handled sterility has assumed something that is not true of us.

References

21 CFR 211.94, "Drug product containers and closures". (a) "Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements." (b) "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product." (c) "Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated." (d) "Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures." Part 211 is current good manufacturing practice for finished pharmaceuticals; compounding under section 503A of the Federal Food, Drug, and Cosmetic Act carries conditional exemptions from certain requirements including cGMP, and nothing here asserts that this section applies to any particular compounder. law.cornell.edu

The Davis Pack Supply catalog, checked catalog-wide on 19 October 2026. No container or closure in this catalog is supplied sterile or depyrogenated, and we publish no sterilization or depyrogenation data. There is no oral dosing syringe and no bottle adapter anywhere in the catalog. We publish no certificate of analysis, no extractables or leachables data and no methods of testing.

The Davis Pack Supply catalog, measured 19 October 2026. Specification labels present on the 486 rows indexed to this group: Color on 486, Material on 484, Case pack on 482, Neck finish on 473, Height on 454, Temperature range on 410, Liner on 350, Width on 126, Capacity on 106, Recyclable on 5.

Written from 21 CFR 211.94 and from the catalog as it stood on 19 October 2026. Part 211 is current good manufacturing practice for finished pharmaceuticals; compounding under section 503A of the Federal Food, Drug, and Cosmetic Act carries conditional exemptions from certain requirements including cGMP, and nothing here asserts that 211.94 applies to any particular compounder. Our chemical resistance figures are a five-point rating on a resin family, not a compatibility finding for a formulation. No container in this catalog is supplied sterile or depyrogenated, and we publish no extractables data and no certificate of analysis.