Dear sir
Can you clear to me the principle/ basic of Lag time. How to calculate the lag time during the sterilization cycle of the Autoclave.
Dear:
the cycle time of sterilizaiton is dependant on your target-matter, It is different for the product and some other supporting tools.
Best Regards
WISTON
Hi
The lag time is the time difference between first sensor reching 121.1 to all sensors reaching 121.1
yes lag time is the time in minute when ur first sensor reached 121.1 or ur set temperature and last sensor (external sensor) reached 121.1 or set temperature, lag time calculated at the time of Heat penetration cycle.
dear
when we are doing the heat penetration study in autoclave .it is important that temp. should be reached in every place , lag time is the difference of temp (121.1 C) reached on first sensor to last sensor, for upto 800 liters capacity autoclave upto 15 sec. and for above volume from 800 liters 30 sec,
(lag time is the time required to reached the temp 121.1 from first sensor to last sensor)
with
Warm Regards
Rajeev Sharma
Sr. Executive QA - Validation
Hello sir,
I am new here,
But want to ask something about lag time described by you, As suggested by you 15 and30 sconds, but what about Higher capacity autoclave and also What about uniformity criteria, how can we calculate Uniformity,
Which is the correct source for reference ?
Pls.reply
Gauav
9924183373
QA Executive.
Dear All
15 second for below 800 ltrs and 30 seconds for above 800 ltrs Acceptance criteria is only for equilibrium time which is calculated during empty chamber heat distribution.
Don’t confuse and mix the lag time and equilibrium time. Both thing are different.
For more clarity refer HTM 2010
[quote=askaboutvalidation]Hello sir,
I am new here,
But want to ask something about lag time described by you, As suggested by you 15 and30 sconds, but what about Higher capacity autoclave and also What about uniformity criteria, how can we calculate Uniformity,
Which is the correct source for reference ?
Pls.reply
Gauav
9924183373
QA Executive.[/quote]
[quote=mahaksinghchaudhary]Dear All
15 second for below 800 ltrs and 30 seconds for above 800 ltrs Acceptance criteria is only for equilibrium time which is calculated during empty chamber heat distribution.
Don’t confuse and mix the lag time and equilibrium time. Both thing are different.
For more clarity refer HTM 2010[/quote]
I agree with Mahak Singh, lag time & Equilibrium time is different. Lag time may be 2 min, 3 min & may be more than that or less. for example , std sterilization time is 15 min but you will see for media preparation companies are having the sterilization time 20 mins. In case for garment cycle, equipment cycle or some other load pattern, people fix the sterilization time for 30 min, 40 min, 45 min , 60 mins. It is fixed only during heat penetration study, in how much time the set temp reaches in all sensors (in side the load) from yours reference sensor (from which sensor you calculate your std cycle time).
Exp: Set temp is 121 and hold time is 15 min, ch-1 is ref sensor and ch-5 is in load, you started the cycle at 10:00 and temp reached 121 at ch-1 at 10:45 but at ch-5 it reaches at10:48. In this case 03 min is lag time. For further sterilization you should add 03 min in hold time (15 min) and now hold time should be 18 min in lieu of 15 min.
Its my view, may be some others have different view, pls let me know too.
Thank you very much.
In the industry practices the Equilibrium time is measured during both Empty chamber & Loaded chamber validation studies.
Both having the same requirement.
This values are derived from HTM2010 but it is obsolete now.
So, anybody knows what is the current guideline to be followed for the autoclave validation???