Skip to main content

Procedure for Calibration of Balances in pharmaceutical industry

 MONTHLY CALIBRATION OF BALANCES 

For monthly Calibration of Balances check following parameters-

1. Accuracy - verify the balance with minimum weight (least count × 100), 5%, 20%, 50%, 90% capacity of respective balance capacity.

Tolerance - the variation if any should be ± least count of the balance or ± 0.2% of certified standard weight used whichever is higher 

 2. Reproducibility - 

Check the reproducibility by using minimum standard weight of balance capacity. Place the weight in the middle of the weighing pan observe the displayed value 

Then calculate the %RSD by following formula 

RSD= SD×100 / X 

Where, 

X= mean of the individual value

Acceptance = %RSD should not be more than 2.0%

3. Eccentricity 

Eccentricity is the difference between the weight placed in centre and at peripheral points of the weighing pan 

Labels:

Popular posts from this blog

Disintegration Time for tablets as per IP, BP and USP

Disintegration Time:- Uncoated Tablet NMT 15 min, in water with Disc 37 0 C ± 2 0 C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab , and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. According to USP 2 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Soluble Within 3 min in water at 25 0 C ± 1 0 C ( IP ) & 15 – 25 0 C ( BP ) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 30 0 C ( IP ) & 5  min in 200 ml water at 15-25 0 C ( BP ) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 37 0 C ± 2 0 C. If 1 or 2 tabs fail, repeat for 12 tabs. Click to Buy Here
Read more

Weight variation limit for tablet and capsule.

Weight Variation Limits:- 1) For Tablets  IP/BP.                           Limit.                          USP 80 mg or less.             10%                     130mg or less  80 mg to 250mg.       7.5%               130mg to 324mg 250mg or more.          5%               More than 324mg 2) For Capsule:- IP Limit Less than 300mg 10% 300mg or More 7.5%
Read more

Basics and use of HVAC system in pharma

HVAC is an essential aspect in pharmaceutical industry as factors like temperature, relative humidity and ventilation have a direct impact on the quality of the pharmaceutical product. The designing of the HVAC should be sorted out while design concept of facility is in progress as it is linked to the architectural layouts like air locks, doorways and lobbies. Once the HVAC system is properly designed and installed it not only helps to create the required room pressure differential cascades but also prevents the cross contamination. Basically an HVAC system works by transferring the heat and moisture into and out of the air and controls the level of the air pollutant either by removing them or diluting them to a particular level. TECHNOLOGY OVERVIEW: HVAC system varies according to the size and installation capacity within a facility but the basic components remain almost the same. LAYOUT OF A TYPICAL BASIC HVAC SYSTEM HEATING SYSTEM: The heat source is either a furnace or ...
Read more