AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question Please what are the various classes of areas in the pharmaceutical manufacturing plant with reference to temperature and relative humidity?
what are the specific temperatures and corresponding relative humidity for:
i) cold room
ii)cool room
iii)room temperature
What are the specifications of temperature and relative humidity for other areas of the plant?
Is there a way of coverting temperature to relative humidity?
Answer According to the USP (Genral Notices), the following definitions apply:
Freezer— A place in which the temperature is maintained thermostatically between 25 and 10
( 13 and14 F).
Cold— Any temperature not exceeding 8 (46 F). A refrigerator is a cold place in which the
temperature is maintained thermostatically between 2 and 8 (36 and 46 F).
Cool— Any temperature between 8 and 15 (46 and59 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 2 and 8 (36 and 46 F),that allows for excursions in temperature
between 0 and 15 (32 and 59 F) that may be experienced during storage, shipping, and
distribution such that the allowable calculated MKT is not more than 8 (46 F). Transient spikes up to 25 (77 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 20 to 25 (68 to 77 F); that results in a mean kinetic
temperature calculated to be not more than 25 ; and that allows for excursions between 15 and30
(59 and 86 F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean
kinetic temperature remains in the allowed range, transient spikes up to 40 are permitted as long as they do not exceed 24 hours. Spikes above 40 may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25 ”, 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. (See also Pharmaceutical Stability 1150 .) 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 30 and 40 (86 and104 F).
Excessive Heat— Any temperature above 40 (104 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.
