小中大MKT is expressed as:
MKT 表达式如下:
Where:
其中:
ΔH = activation energy (typically from 60 to 100 kJ/mol for solids and liquids)
ΔH=活化能量(通常对于固体和液体来说,从60 kj/mol 到100kj/mol)
3 / 4
R = 8.314472 J/mol-K (universal gas constant)
R=8.314472J/mol-K(通用气体常数)
T = temperature in degrees K
T=温度(用K 为单位)
n = the number of sample periods over which data is collected
n=数据搜集数量
Note : ln is the natural log and ex is the natural log base.
注意:ln 是自然对数e 是自然对数的底数
The above equation is valid only when the temperature readings are taken at the same
interval. A more general form for the above equation can be expressed as:
上述的公式只是适用于同样的时间间隔,应用更广泛的公式如下:
Where:
其中:
to are time intervals at each of the sample points
t1 至tn 为相应温度的时间
When = = = , this equation will be reduced to the former equation.
当t1=t2=…=tn 时,该公式和就上面的一致了。
WHY IS MKT IMPORTANT IN THE LIFE OF PHARMACEUTICALS AND PERISHABLE
GOODS?
为什么MKT对于药品和不耐久的货物来说是十分重要的呢?
The pharmaceutical and food industries are two closely regulated markets. The FDA
provides regulations that require warehouse and shipment temperatures to be closely
controlled and monitored. In addition, the FDA requires well-documented verification of
4 / 4
these storage environments and any corrective actions taken if temperatures exceed
specified storage conditions.
食品和药品是两种非常接近的管理市场,FDA 制定了法规要求对参数和运输温度进行严密
监测和控制。另外,FDA 要求归档环境温度确认和任何温度超出规定储存温度的纠正措施。
The calculation of MKT is regarded by the FDA as an action taken to verify if a particular
perishable has exceeded storage conditions.
MKT 计算被FDA 认为是确认某一不耐久物品超出其储存条件的纠正措施。
In addition to compliance with the FDA regulations, MKT can help Distributors and
Manufacturers determine if improper storage or handling of goods, that might have
occurred during shipment and/or unloading, has affected the shelf life of the their product.
除了FDA 的法规要求外,MKT 可以帮助分销商和制造商确定在运输或卸载时错误的储存或
处理物品对产品保存期限的影响。
Other considerations:
其他注意事项:
It can assume activation energy of 83.14472 kJ/mol for its calculation. In fact, any value
between 60 and 100 kJ/mol, which covers most solids and liquids, will have only a small
effect on the final value.
ΔH 可以选用83.14472 kJ/mol 参与计算。事实上,对于固体和液体来说,任何在60 至
100 kJ/mol 都可以,对于结果的影响很小。
Of course, extreme temperatures even over a very small time period can damage most
foods or pharmaceuticals. Per the above example, putting an egg in a 75º C oven for 1/2
hour will bring the MKT to 45.4º C, but the egg will be irreversibly damaged (i.e. cooked).
Consequently, there are maximum and minimum temperature limits established by the
FDA.
当然,极端的温度在很短的时间内都可以对大部分药品或食品造成损坏,比如在上面的例子
中将一个鸡蛋放入75℃箱内0.5 小时,MKT 计算值为45.4℃,但是显然鸡蛋遭到了不可逆
的损坏(比如已经煮熟了)。所以,FDA 会建立最大和最小的温度限。