Thursday, 19 January 2017

Pharmaceutical Steam

Steam is a water in the gas phase (liquid to vapor). Which is formed when water boils.

Steam is a water vapor condenses.
2 types of Steam 
     1.       Process steam or plant steam
     2.       Pure steam  (Clean steam)

        1.       Process steam or plant steam:
  • Plant steam is steam used for heating systems and not be in contact with sterile goods.
  • This steam used for utility system, boiler……etc.
  • Plant steam generate from the raw water.
  • Les pure “plant steam “ may be used for steam sterilization of non-product contact nonporous loads.

  2.       Pure steam  (Clean steam):
·         Pure steam is also called Clean steam.
·         Free of chemical and biological contamination.
·         Pure steam generation from WFI (Water For Injection).
·         Pyrogen free
·         Pure steam specification meet all the parameters of WFI (Water For Injection).
·         Free from all chemical and biological impurities.
·         Pure steam used Pharma and Health care industries.
·         Medical devices sterilization used the pure steam (clean steam).
·         Standard guidelines for pure steam EN (European Norms)285, HTM (Health Technical Memorandum) 2010.

Physical properties required for pure Steam.

Non-condensate gases
(NH3(ammonia), CO2, N2, O2 and Halogenated Hydrocarbons.)
Not More Than 3.5 percent (Max)
Dryness valve Porous Load
0.9 percent (MIN)
Metal load
0.95 Percent (MIN)
Super Heat value
25 0C (Max)
Bacterial Endotoxin
<0.25 Eu/ml
pH
5 - 7
Conductivity
1.1 μs/cm at 20 C
Moisture
<5 %
Germs (micro organisms)
10 cfu/100 ml

What is the fumigation and fogging?

What is the fumigation and fogging?