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Questions and Answers on USP 797

Questions and Answers on USP 797: Answers Provided by Eric S. Kastango, MBA, RPh, FASHP:

  • E9 Question:  Are there any temperature guidelines that apply for 797?
     
  • E9 Answer:  There are several temperature requirements for drug storage area, refrigerators, freezers and conditions.  They are as defined in USP 29-NF 24: 

Freezer— A place in which the temperature is maintained thermostatically betweeno -25o and -10o (-13o and 14 F).
Cold— Any temperature not exceeding 8o (46o F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2o and 8o (36o and 46o F).
Cool— Any temperature between 8o and 15o (46o and 59o F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.
Controlled Cold Temperature— This temperature is defined as the temperature maintained thermostatically between 2o and 8o (36o and 46o F), that allows for excursions in temperature between 0o and 15o (32o and 59o F) that may be experienced during storage, shipping, and distribution such that the allowable calculated MKT is not more than 8o (46o F). Transient spikes up to 25o (77o F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise.
Room Temperature— The temperature prevailing in a working area.
Controlled Room Temperature— A temperature maintained thermostatically that encompasses the usual and customary working environment of 20o to 25o (68o to 77 oF); that results in a mean kinetic temperature calculated to be not more than 25o; and that allows for excursions between 15o and 30o (59o and 86oF) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40o are permitted as long as they do not exceed 24 hours. Spikes above 40o may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25o”, or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.
An article for which storage at Controlled Room Temperature is directed may, alternatively, be stored and distributed in a cool place, unless otherwise specified in the individual monograph or on the label.
Warm— Any temperature between 30o and 40o (86o and 104o F).
Excessive Heat— Any temperature above 40o (104o F).
Protection from Freezing— Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.
Dry Place— The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity.
Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.
 
There are no hard and fast temperature or humidity requirements for cleanrooms.  Ideally, the controlled compounding rooms should be 66F +/-2 F to ensure employee comfort when fully garbed.  Relative humidity (RH) recommendations should be between 30 and 65 % RH. 

(Answer provided as a courtesty to usp797.org, inc. by Eric S. Kastango, MBA, RPh, FASHP. Please note that usp797.org, inc. is not responsible for this answer.)

  • About Eric S. Kastango: Since its inception, Eric S. Kastango has been at the forefront of USP <797>. He is an elected member of the United States Pharmacopoeia Sterile Compounding Committee (2005-2010). Over the years, he has held multiple American Society of Health-System Pharmacists chairmanships and committee positions. He was responsible for creating the “Comprehensive Sterile Compounding Compliance Gap Analysis and Risk Assessment Tool.” In this capacity, Mr. Kastango frequents pharmacy events as an expert speaker, contributes to industry journals, and teaches. Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and a MBA from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation, which has 72 pharmacies in 44 states. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation, and has made over 100 presentations on a variety of pharmacy practice topics.  Mr. Kastango is the President and CEO of Clinical IQ, and can be reached as follows:

Mr. Eric S. Kastango – President and CEO
Clinical IQ, LLC 
184 Columbia Turnpike, #282 
Florham Park, NJ  07932 
Tel: (973) 765-9393 --- www.clinicaliq.com

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