Physical Specification for HSG

Size Actual Typical Fill Weights

Volume (ml) (mg)
0.70 Powder Density

000 in serial number it is 1 stin 1.37 960

In 100 only we get first 00 that capsule size that means “1” and have
means 100a nd we have 5 3 zeros that means 3 that means 1.3
Zeros up to here that means 5
just subtract 5 from 100 we get
00 0.95 665
95 tat is second value 95-37=58
0 0.68 If we add +10 to 58 475
We get first zero
in 10 we get 3 rd. one First
1 2 0.50 that is .68 350
In entire table we get one in
After one we get and
1.37 value after one just 2 so do ½ we get 0.50
0.37 260 2 and 2 Nd
remove 1 from 1.37 so we get last are
.37 that is the value for 2 nd 3 0.30 210 from last
capsule size zeros
4 0.21 145 also have 5
-9
5 -8 0.13 90
 CAPSULE

Mothes and Dublanc, two Frenchmen, are generally credited with the
invention of the gelatin capsule.

Capsules may be classified as either hard or soft depending on the nature

of the capsule shell:
 Hard Gelatin Capsules
 Soft Gelatin Capsules

Hard Gelatin Capsule (Dry Filled Capsule)

The hard gelatin capsule consists of a base or body and a shorter cap, which fits firmly over the base
of the capsule. It is mainly used for Powder, Granules, Pellets.

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, 1185-1190
 5 letters that means 5 and b is the second letter in alphabets
Composition that means 2 so totally 25 and we have “o” it looks like 0 tat
means 250
Gelatin

 B loo m Strength (Gel strength)–It is measured in Bloom Gelometer. It indicates

strength of cross-linked gelatin molecules. It should be 150 – 250 grams.
Do minus this 100 from it
 viscosity for gelatin can range from 25 to 45 millipoise,.
Bloom is determined by measuring the +20
weight in grams required to move a plastic plunger of 0.5 inches in diameter,
4 mm deep into a 6.66% gelatin gel that has been held at 10°C for 17 hours.
Low-viscosity (25 to 32 millipoise), high-Bloom (180 to 250 g) gelatins

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, 1185-1190
  Type A gelatin
acid treated precursor

It is about from pork skin. It gives elasticity/plasticity and clarity to the shell
.
Isoelectric pH is 9.0 and obtained from

If you rotate p it looks like

q

 Type B gelatin–it is derived from Alkali treated

 It is obtained from bone. It imparts toughness to the shell

Isoelectric pH is 4.7,.

It is 2 letter in alphabets that means 2 9/2= 4.5+0.2=4.7

If You Divide This Type A Gelatin PH Value With By 2 And Add 2 We Will Get The Type B Gelatin Isoelectric Point

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, 1185-1190
  Acid-Bone gelatin–Isoelectric pH is 5.5 to 6.0. pH is 9.0 rotating it will give you number 6
 Iron Content–Less than 15 ppm
4 letters after 4 number is 5 we know that I looks like 1 so totally 15
Dark Spot on Shell indicates migration of iron sensitive ingredients from the
filled capsule.
 Water or Moisture content (12–15%)

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, 1185-1190
 Hardness of soft gelatin capsule shell

It is determined by weight ratio of dry plasticizer to dry gelatin.

HOME WORKS
Dry Glycerin to dry Gelatin ratio
Hard
4 letters so we put 0 Soft
Medium
in front of it 0.4

+0.2
0.6 0.8
+0.2

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, pp.1185-1190.
 Steps of Manufacturing of Hard Gelatin Capsule Shell

1. Centrifugal Casting method

2. Dip-Pin method (Mostly used on commercial scale)

1. Gelatin Solution
 Raw gelatin and water are mixed in the ratio of 1: 2 and processed at precise temperature in Safrroys melting
systems.
 After vacuum is applied, the solution is received in jacketed tanks.
 Colours and preservatives are also added before taking the solution in to themeachine

The entire cycle of the machine lasts for approximately 45 min

Refrence: Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil,
R. and Anderson, Tablets Special Indian edition, page number 1195
 Filling of Capsule

Steps

1. Rectification–Empty capsule are oriented so that all point in same direction i.e., body end
downward.

2. Separation of Body and

. Dosing of Fill material

are joined by peg rings. it forces the capsule body against the closing plate. Filled capsules are ejected
via compressed air.

collected through Chute.

Refrence: Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil,
R. and Anderson, Tablets Special Indian edition, page number 1195
 WE ARE PRODUCING POLIO VACCINE
Direct filling method

Vibration
Auger filling method Parke–Devis assisted
filling
Imprinting Eli–Lilly

Perry
 company identification information can be placed upon capsule. Indirect filling Osaka
method
 On Empty capsules we do imprinting because .
 imprinting machines based on Off-Rotagravure principle. Dosator Machine

MAHAN IS IMPRINTING MACHINES Teja Bhai Lives In Famous Pace Dazzling

, Markem JKF , Farmatic Zanasi
, Ackley Harnett Tamp-Filling Method Bosch Hoflinger-Karg, Macofar, MG-2

Refrence: Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil,
R. and Anderson, Tablets Special Indian edition, page number 1201:figure 14.5
 Soft Gelatin Capsule (Soft gel/Soft Elastic Capsule/Wet Filled Capsule)

One piece hermetically sealed soft gelatin shell containing a liquid, a suspension or
semisolid. Plasticizer
Composition of Soft Gelatin Capsule Shell GPS

 Gelatin glycerin,
 Water or Moisture Content (6 to 10%) Propylene Glycol
(determined by Toluene Distillation Method or Azeotropic sorbitol
Distillation.)
 Preservatives-Methyl and Propyl Paraben (4:1)
MP
 Colourants–Fd and C, Certified Lakes
Ethyl vanillin 0.1% Flavoring for odor and taste
Titanium dioxide 0.2 to 1.2% Opacifier
Essential oils upto 2% Flavoring for odor and taste

Fumaric acid upto 1% increases the solubility; form aldehydic tanning of gelatin
decreases the solubility

Refrence: Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil,
R. and Anderson, Tablets Special Indian edition, page number 1201:figure 14.5
Capsule weighing machine
1. Roto weigh–It is capsule weighing machine high-speed capsule weighing machine
sold by Eli Lilly and Company. It measures the reflected energy reflected eergy equal to
weight of capsule power X-ray beam.
2. Vericap 1200–It measures the change in dielectric constant thus produced is
correlated to the weight of the capsule
Finishing
1. Pan Polishing-Accelacota tablet coating pan used for capsules polishing
polyurethane cloth. cheese cloth liner is placed in the pan Salt polishing using crystalline
NaCl.

2. Cloth dusting–capsules are rubbed with a cloth that may or may not be impregnated
with an inert oil
Brushing: In this procedure, capsules are fed under rotating soft brushes, which serve to
remove the dust from the capsule shell
Rotosort:

3. Erweka Erweka KEA is dedusting and polishing machine is used to handle the output
from any capsule filling machine
Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, page number1218.
 Capsule washing

Immediately after the manufacturing, capsules are subjected to “naphtha” wash to

remove mineral oil form the outer surface of the capsule.

Important tests
Solubility limit for empty capsules
1. Weight Variation test–20 Capsules
Water Resistance Fails to dissolve in water at
Allowed Variation 20° to 30° C in 15 min.
Less than 300 mg 10%
Acid Solubility Should get dissolved in less
7.5% than 5 min in 0.5% aq. HCl at 36 to 38°C.
Equal or More than 300 mg
Disintegration Test
60 min
Soft Gelatin Capsule SOFT MEANS SIXTY
HARD MEANS HALF OF SOFT GELATIN
Hard Gelatin Capsule DISINTEGRATION TIME 30 min

Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, pp.293-342.
 FGH
Erweka KEA capsule dedusting and polishing machine
Fill means for hard gelatin capsule

can handle up to 150,000 capsules per hour,

Rotoshort A unfilled, loose capsule sorting machine
ABCDEFGH
Accogel Fill Powder in Soft Gelatin Capsule

Gel is in soft nature So it is for soft

Hard
gelatin capsules
Accofill Gelatin
Seidinader Capsule Polishing machine

Rotoweigh A High speed Capsule Weighing Machine

PQR

Accofill Fill Powder in Hard Gelatin Capsule

Rotofill Fill Pellet in Hard Gelatin Capsule
Lachman, L., Lieberman, H.A. and Kanig, J.L., 2009. Industrial Pharmacy. Gilbet S., Banker, Neil, R. and
Anderson, Tablets Special Indian edition, page numbers 1220-1228.