Liquid Borne Particle Count (LBPC)

Instruments:

1.    Clean and particulate free

2.    LBPC (liquid Born Particulate Counter)

3.    Magnetic Stir rod

4.    Powder –free gloves

5.    Sonicator

Reagent: 0.22µn pore size filtered purified/ WFI water.

Blank Procedure:

·         To collect the blank counts.

·         Take clean vessel and 50 ml volume of filtered purified water.

·         Agitate the water in the cleaned glassware by inversion or swilling.

·   Degas by sonicating for about 30 seconds or by allowing to stand for 2 minutes.

·   Vessel is to be placed under the sampler and operating as per operation procedure of the instrument.

·     Withdraw and obtain the particulate counts for four consecutive samples of not less than 10 ml each, discarding the first count.

·      If more than 10 particles of ≥ 10 micron size or 2 particle of ≥25 micron size, sample was discarded.

·         USP recommend If more than 20 particles of ≥ 10 micron size or 5 particle of ≥25 micron size, sample was discarded.

·         In this case, repeat the preparatory steps until the above- criteria are met.

Sterile APIs :

·   10 g of sample with 100 ml of particle free water or with the particle contamination.

·         Manually as take the container sufficiently to ensure dissolution of the drugs.

·         Mix 20 times by inverting before analysis.

·    Degas the pooled solution by sonicating about 30 seconds or allowing the  solution to stand undisturbed until it is free from air bubbles.

(Degas the solution for 2 minutes or till no bubbles observed)

·    Pool the sample in to 200 ml beaker/ vessel on keep the container as is for analysis.

·     Swirl the vessel containing the sample by hand or agitated by mechanical means by magnetic stirrer to suspend particles.

·  Vessel is to be placed under the sample and operated as per the operating procedure.

·         Withdraw and obtain the particle counts for four aliquots, each not less than

10 ml each, discarding the first count.

Interpretation:

• The average cumulative counts, which are obtained in the three runs, are to be taken for calculation

Polled samples: 

=(P x Vt) / (Va X N) 

=P Vt/ Va N

P = is Average particle counts

Vt = is volume of pooled sample in ml Va = sample volume of Analysis

N = number of contains pooled Or wt. of powder constitute

Ex: 1\

 P= 287(≥10µ) = 100ml

Va = 10 ml

 N= 10g

(287 x 100) / (10 x 10) =287

Ex: 2 P=287(≥10µ)Vt=90ml

Va = 10 ml N=9g

(287 x 90) / (10 x 9)=287

·         For all types of product, if the tested material has been diluted to effect a decrease in viscosity or expected counts are very high.

Limits:

By product:

as per USP and EP

·         Not exeed 6000 particle of = ≥10 micron

·         600 particle of = ≥25 micron

By BlanK:

·         Not exeed 0 particle of = ≥10 micron

·         3 particle of = ≥25 micron

Cumulative	10.0000
data		25.0000
Minimum	246.0000	9.0000
Maximum	326.0000	34.0000
Average	287.0000	22.0000
Std	40.0000	12.5300
Deviation	861.0000	66.0000
Total

 ·         Particle matter – meets the requirements for small volume injection.

		LBPC Counts
		(USP/EP/JP/KP)
Large	10um	25 particles/ml
Volume		(100 ml more)
	25 um	3 particles/ml
		(100 ml more)
Small	10um	Not more than 6000 particles/container
Volume		(100 ml more)
	25 um	Not more than 600 particles/container
		(100 ml more)