HEPA Integrity!

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Sirs,
Plz can anyone tell me how to use Poly Alpha Oliphins for HEPA integrity?
Or is there any alternative to DOP?
How is (the alternative method) it performed?

2

I think mineral oil is sometimes used as an alternative DOP.

3

[quote=Sachin Patil]Sirs,
Plz can anyone tell me how to use Poly Alpha Oliphins for HEPA integrity?
Or is there any alternative to DOP?
How is (the alternative method) it performed?[/quote]

Dear Sachin,

  1. First of all, make aerosol of Poly Alpha Oliphins by aerosol generator, POA makes 0.3 micron size aerosol, this aersol do enter at the blower of HEPA, then scan this aerosol photometer probe via upstream and set the 100% value then scan the filter media by photometer detector.The standard requires that the challenge aerosol is used as the 100% reference for the downstream measurement and must be homogeneously mixed resulting in an even challenge to the filter. The measurement downstream of the filter is then directly in percentage penetration. The filter gasket, frame and media are scanned for leaks. The maximum permissible leak is set at 0.01%, although lower limits may be used.
  2. Previously DOP stand for Di octyl thalate, but due to carcynogenic property of DOP, it has replaced by POA , now DOP stand for dicreate oil particle test.
    The second method offered in the standard is the particle counting method. This method also requires the filter is evenly challenged with a known recorded concentration of aerosol, an aerosol diluter and a discrete particle counter.
    This method is relatively new and uses a DPC (Discrete Particle Counter) test method. The standard claims this method is good for measurements to 0.000005% and better. This exceeds the requirements for the pharmaceutical industry and is really good only for cleanrooms ISO Class 4 and lower. This is because the particle counter is a batch measuring device and is not designed to make continuous measurements. Background particles in a non-unidirectional cleanroom will cause the detection of false counts, making the method difficult and less reliable.

Thanks

4

Hi,
A.2 Yes. Dioctyl phthalate aerosols also called Di (2-ethylhexyl) phthalate, di-sec octyl phthalate, DOP, or DEHP, have long been used to test the integrity of high efficiency particulate air (HEPA) filters but concern about the potential health effects to people working with DOP test aerosols has led to a search for a safer equivalent replacement.
The product of choice from US Army testing with assistance from various private companies was a Henkel Corporation (Emery Group) product called Emery 3004 PAO. This product is a polyalphaolefin (POA) in the 4 centistoke (4 cSt) viscosity grade, used primarily as a lubricant base stock for oils, lubricants, and electrical/hydraulic fluids.
Emery 3004 (POA) can replace DOP in HEPA integrity testing.

5

Try TiCl4 for smoke test pattern

6

Dragger smoke test is easily avialable for air pattern test.

Thanks

7

sir good afternoon
whats the process of rubber bungs sterilization.pl explain

8

[quote=rvs1232003@rediff.com]sir good afternoon
whats the process of rubber bungs sterilization.pl explain[/quote]
after bungs washing transfer process,in autoclaving thats bugs deep in wf i or keept in perforated container

9

[quote=rvs1232003@rediff.com]sir good afternoon
whats the process of rubber bungs sterilization.pl explain[/quote]
after bungs washing transfer process,in autoclaving thats bugs deep in wf i or keept in perforated container

10

pl explain

11

Hello to all,

Can anybody share a knowledge about how to evaluate product campaign length for multi product facility ?