In sterile area water loop system pipes r made of 316L?
316L exhibit better corrosion resistance and are stronger at elevated temperatures so it is used in wfi pipe line.
There are a variety of different types of 316 stainless steels, including 316 L, F, N, H, and several others. Each is slightly different, and each is used for different purposes. The āLā designation means 316L steel has less carbon than 316 steel.
317 and 317L have higher molybdenum content and are better for overall corrosion resistance but is very costly.
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what is the temperature of flame used for sealing of ampule?
Gass used for flame?
Temperature should be approx 1040 degree centigrade for 50 sec exposure time.it is theoretical.practically operater set the flame and observe at which point sealing of ampoule is OK because it also depend on line speed.
LPG and Oxygen are used for sealing.flame should be blue.
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for thermolabile drugs this temp may not degrade the product?
it will not affect the thermolabile product because the flame is given at the tip of ampoules and thickness of glass is very less in ampoule so it gets cool easily in short time.
Practically used method is tip sealing or pull sealing?
which is best?
Tip sealing method is best.seall is made of thicker glass,very strong ,and uniform.
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same temp and same procedure for both tip n pull sealing or some difference?
The Tip Seal Method (a.k.a. Bead Seal Method) involves melting the glass at the top of the
ampule downward. The ampule is constantly spinning during the sealing process to create a
rounded, hemispherical seal.
The Pull Seal Method melts the glass in the middle of the ampule neck. When the glass is
melted, the top of the neck is pulled off with a small amount of thin glass melted to create the
seal.
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thnks for all
if we have 3 days off the hvac of sterile area will remain function to maintain sterity?
or we will shutdown n re clean area after vacations?
Proper cleaning and fogging should be done.check the environment data.if it is under limit you can start production.
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ok il use
Inadequate equipment maintenance is your most likely root cause.
Inadequate equipment is root cause because we had to use jacketed pressure vessel to connect hot and cool system to maintain the temperature of solution in short period.
If the HVAC, PMS and BMS system is functioning well and No critical alarms during vacation, then no need to go for fumigation.After cleaning and sanitization activity you can proceed as per SOP.
Thanks