ispe good practice guide

1、ISPE Good Practice GuidePackaging, Labeling, and Warehousing Facilities 20126.3.1 TemperatureRoom temperature may be a critical parameter for both exposed and not-exposed operations. Most products,materials, and processe

2、s can tolerate a wide range of temperatures. The width of this range decreases as theexposure time increases. Temperature requirements for processing or storage will be based on product requirements.Personnel comfort sho

3、uld be considered in establishing room temperature requirementsProduct requirements are often defined by “controlled room temperature,” as defined according to the USP GeneralNotices and Requirements “Preservation, Packa

4、ging, Storage, and Labeling” [16] as follows:“A temperature maintained thermostatically that encompasses the usual and customary working environment of 68°Fto 77°F (20°C to 25°C); that results in a me

5、an kinetic temperature calculated to be not more than 77°F (25°C) and that allows for excursions between 59°F and 86°F (15°C and 30°C) that are experienced in pharmacies, hospitals,and wareh

6、ouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C(104°F) are permitted as long as they do not exceed 24 hours. Spikes above 104°F (40°C) may be per

7、mitted if themanufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 77°F(25°C),” or other wording based on the same mean kinetic temperature. The mean kinet

8、ic temperature is a calculatedvalue that may be used as an isothermal storage temperature that simulates the non-isothermal effects of storagetemperature variations.”It should be noted that specifying tighter requirement

9、s than those actually required will not result in a better designedHVAC system, but will generally result in a system that is more expensive to purchase and maintain.6.3.2 HumidityRoom humidity may affect exposed product

10、 or materials that are sensitive to moisture in the atmosphere. Humiditylevels generally have negligible effect on sealed containers or aqueous product; however, liquid product can losemoisture to a low humidity room ove

11、r an extended period of time. Humidity also can affect identify the locationswhich are representative of the environmental extremes within the space, to assist in scientifically determining wherethe permanent area monito

12、ring sensors should be placed. The duration of any mapping can vary; in general, itshould, as a minimum, cover a representative period at the extremes of the external environmental conditions (e.g.,coldest winter and hot

13、test summer days). Some mapping also can be done with different amounts of material storedin the area to be mapped. The study also should consider the affect of the stored product on the performance of thearea (refer to

14、USP [38]).There are a number of approaches to temperature mapping, including:? Computer Modeling? Engineering Assessment10.1.1 Computer ModelingComputer models may be used to predict the probable locations of the enviro

15、nmental extremes during summer andwinter. This information can be used to suggest the location for the sensors used for a temperature mapping study.10.1.2 Engineering AssessmentAn experienced individual, knowledgeable in

16、 air distribution patterns should consider the facility characteristics indetermining the location of the temperature mapping sensors, including:? Product Storage Location? Environmental Influences: doors, external walls

17、, etc.? HVAC system performance characteristics (supply and return grille/register location and performancecharacteristics): unit heater location may also be significant? Geometric shape of the facility? Location of the

18、facility in relation to the potential influence of external conditions? Heating/Cooling Loads: these establish the anticipated space differential temperature between the outdoorenvironment and the air supplied by the HVA

19、C system.Multiple temperature sensors should be located at different levels of the product storage system. Supply and returnair temperatures also should be monitored and recorded.A typical proposal for the location of ma