Category Archives: Stability

Controlled Room Temperature

Temperature

Hello good people of the world! Today’s post is about controlled room temperature, which is of importance for any space holding drug products, including manufacture, storage, and transportation. Storage temperature requirements are closely related to drug stability, so are an important focus of regulatory agencies.

US pharmacopeia has at least two applicable monographs:

Good Storage and Shipping Practices

and

Pharmaceutical Stability

ISPE summarizes the general industry approach nicely in the Good Practice Guide on Cold Chain Management (not free but available here):

“‘Controlled room temperature’ indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.”

How do you control your room temperature space? Leave a comment below and please share this post with whomever you think would benefit.

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Container Closure Integrity Testing

Hello good people of the world! The present post concerns itself with Container Closure Integrity (CCI) testing. CCI testing is an integral part of packaging validation, involving primary packaging such as ampoules, blisters, bottles, vials, syringes, tubes, etc. Biopharmaceuticals are typically packaged in hermetically-sealed containers to prevent the ingress of any liquid or gas that could be reactive or carry microorganisms. Packaging may also by light-resistant, if light could affect the properties of the product.

There are three regulatory/industry guidelines typically cited in the U.S. regarding CCI testing:

  1. FDA Guidance for Industry (2008), Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
  2. PDA Technical Report No. 27 (1998), Pharmaceutical Package Integrity (not available for free)
  3. USP <1207>, Sterile Product Packaging – Integrity Evaluation

CCI testing is either physical (bubble, liquid tracer, vacuum/pressure decay, dye ingress, etc.) or microbial (microbial ingress).

Each has it’s advantages and disadvantages, as shown in the below from American Pharmaceutical Review:

When should these tests be performed? CCI testing is applicable to new container closure systems and can be performed on newly sealed containers to validate sealing performance, and then annually and at the expiration date to validate stability.

What are your preferred methods of Container Closure Integrity Testing?

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