undiluted standard tuberculine.

The reactions in each fowl are read after

twenty four hours and forty eight hours and if comparable the product is
passed for issue.

5. Labelling and Storage Should comply with the requirements of

'Labelling' and 'Storage' as laid down in the general monograph on 'Diagnostic
Antigens'.

6. Expiry Date The date of expiry of potency shall be not more than two
years from the date of manufacture when stored at 2°C to 4°C.

PART IV

GENERAL

1. For the purposes of this Schedule any test or method of testing described
in the 1100[British Pharmacopoeia (Veterinary)] shall be deemed to be a method
approved by the licensing authority.

2. The licensing authority shall publish in the Official Gazette from time to
time particulars of any test or method of testing approved by him.]
1101
[SCHEDULE F(II)

(See rule 124C)

STANDARDS FOR SURGICAL DRESSINGS

Synonyms Bandage Cloth, Bleached Bandage Cloth, Rolled Bandage,

Open Wove Bandage, Cotton Bandage Cloth.

Bandage Cloth consists of cotton cloth of plain weave made from machine
spun yarn of suitable count to comply with a bleached count between 20 tex and
25 tex for warp and between 25 tex and 30 tex for weft. The fabric contains no
filling, sizing or dressing material. It may be supplied uncut and folded or cut to
suitable sizes and rolled.

Description for uncut bandages Uncut bandages are cotton cloth of plain
weave, in one continuous length showing no joints or seams, with well-formed

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selvedges. The cloth is bleached to a good white, is clean and odourless and
reasonably free from weaving defects and from seed and leaf debris.

Description for cut bandages Same as for uncut bandages, except for
selvedges which shall not be included in cut bandages. In addition, both the
extremes and edges of cut bandages shall be straight and evenly cut, with
reasonable freedom from loose threads.

Threads per dm Wrap not less than 150 and weft not less than 85.

Weight in glm2 57 + 5.

Length and Width The length and width shall not be less than 99 per cent
each of the length and width stated on the label. For cut bandages, each of the
bandages in a packing complies with this requirement.

Foreign matter Not more than 2 per cent.

Fluorescence When viewed under screened ultra-violet light, not more than
occasional points of fluorescence are observed.

Packing, Labelling and Storage Bandage Cloth shall be packed securely so

as to allow normal handling and transport without tearing and exposing the
contents. In packages of cut and rolled bandages, each bandage shall also
individually be wrapped in a suitable paper. The net content is stated on the
label in terms of length and width. Bandage Cloth must be stored in packed
condition, protected from dust. The packings of Bandage Cloth shall be labelled
prominently with the words "Non-sterile".

Absorbent Gauze Synonyms Gauze; Unmedicated Gauze; Absorbent

Cotton Gauze.

Absorbent Gauze is cotton fabric of plain weave, supplied in various widths

and lengths. The Gauze is bleached and free from any sizing, dressing or filling
material. The yard used is machine spun cotton yarn, of suitable count to
comply with a bleached count between 17 and 25 tex in the finished fabric.

Description Cotton cloth, plain weave, with a simple selvedge present on

both sides to prevent unravelling of yam. The cloth is bleached to a good white,

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is clean, odourless, reasonably free from fabric defects and adhering sand debris
from cotton seeds and leaves, or any other foreign matter.

Threads per dm Wrap not less than 75 and weft not less than 55.

Weight in glm2 30 + 5.

Length and Width Not less than 98 per cent each of the length and width
stated on the label.

Absorbency Average sinking time not more than 10 seconds.

Fluorescence When viewed under screened ultra-violet light not more than
occasional points of fluorescence are observed.

Foreign matter Not more than 1 per cent.

Sterility If sterile, the contents comply with the test for sterility.

Packing, Labelling and Storage Absorbent Gauze is folded and packed

with such material and so securely as to protect its absorbency and allow normal
handling and transport without tearing and exposing the contents. The net
content is stated on the label in terms of length and width. The packages shall be
labelled prominently with the words "Non-Sterile". If sterile, it shall be so stated
on the label, and the packing method and material shall be such as to maintain
the sterility. The absorbent Gauze must also comply with the Sterility Test.
Absorbent Gauze must be stored in packed conditions protected from moisture
and dust.

METHODS OF TEST

Defect in fabric The sample is unfolded, opened and held against diffused
daylight or spread on black topped table to locate and identify prominently
visible defect in yam and fabric construction. The fabric shall be reasonably free
from holes, slubs, snarls and naps as well as the following:

Odour Misty odour, or any objectionable smell like that of chemicals or

materials used in sizing and bleaching.

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 Skewness (For Bandage Cloth only). A condition where warp and weft do
not keep at right angles to each other.

Defective selvedge The selvedge tearing and allowing yam to unravel, and
loop formation at selvedge.

Crack Prominent streaks of space or gaps between warp or weft yarns.

Double ends More warp threads woven as one, due to wrong draw.

Sloughing Entanglement in the fabric of a bulk of yarn that has slipped off
the weft yam due to loose widing.

Measurement to length and width Length is the distance from end to

end, along one edge of the fabric, and width is the perpendicular distance from
one edge to the opposite edge.

Length Fix a metre scale to a table or mark off the division of one metre on
a table edge. Starting from one end, spread the fabric flat on that table in a
single layer keeping one selvedge parallel to the scale; smoothcn the fabric
without stretching it, to avoid creases, and mark off with a coloured pencil, on
the selvedge exactly one metre. Shift the fabric and measure in the same way
the second mete and so on for the entire length of the fabric making a mark at
each metre. Note down the total length in metres. Repeat this at the opposite
selvedge, as well as on the fabric folded approximately about middle. The
average of the three readings is the length. For cut bandages, one measurement
at the middle of the bandage by folding it length-wise will suffice.

Width Lay the portion of the fabric to be measured flat and smooth on
table, but do not stretch fabric except sufficiently to render it creaseless. At the
place where mark had been made on the selvedge in measuring the length
measure the perpendicular distance to the opposite selvedge with a metre scale.
Note the width, repeat this at every mark made in measuring the length. The
average of all the readings is the width of the fabric. For cut bandages, width
shall be measured at every 50 cm., and average reported as width.

Threads per dm (For samples not less than 15 m. in Length.)

Weft At the third metre from one extreme locate three places one at about
5 cm. below the top selvedge, a second in the middle and third at about 5 cm.

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above the bottom selvedge, all three in a vertical row. Take a rectangular plate
(made of suitable material such as plastic or aluminium) with the rectangular
opening of 5 cm. x 10 cm. cut in it. Keep the plate on the fabric horizontally so
that the left 5 cm. side and bottom (10 cm. side) edges of the opening coincides
with a weft and warp yarn respectively; count the number of weft yams within
the opening for the length of 10 cm. Repeat this at the other two selected places,
and note down the average of three readings. Repeat this at every third metre in
the sample and calculate the average weft per dm.

Warp Keep the rectangular plate, this time vertically with left (10 cm.
side) and bottom (5 cm. side) edge of opening coinciding with a weft and warp
yam respectively. Count the number of warp yams within the opening for 10
cm. and note down. Repeat this for about 10 selected places in the samples
taking care that the same set of warp yarns is not counted more than twice and
calculate the average warp per dm. Magnifying glass mounted on stand may be
used for counting.

For samples less than 15 m. in length, locate as many different places as the
dimension of the fabric permits, the total being not less than 10 for each sample,
and calculate the warp and weft per dm. as above.

For cut bandages, all the warp threads in the samples are counted, taking
care to leave 5 mm. at the cut edge, and weft is counted at every 50 cm. at any
place about the middle of the bandage.

Weight per unit area For samples not less than 15 m. in length, cut out
pieces of fabric from the entire length of the sample, representative places being
taken from areas at every third or fourth metre so that the total area of all the
pieces so collected is not less than 3 sq. metre. Weight the pieces accurately,
measure the dimension of each of the pieces and calculate the area and weight
of all the pieces. From the average area and average of weight thus obtained,
calculate the area per sq. metre.

For samples less than 15 m. in length, take pieces in such manner that the
total area of the selected pieces is not less than 20 per cent of the total area of
the sample

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 For cut bandages, pieces of 50 cm. in length, cut from 5 different cut
bandages in a packing should be taken and weight calculated as an average of 5
readings.

Absorbency Take a glass trough of approximate size length 30 cm. x

width 30 cm x depth 25 cm. with straight thick walls and flat bottom. Fill it
almost full with distilled water leaving only about 5 cm. from the top rim of
trough. Maintain the water at 27l

Cut out from any five places located equidistant down the length of the
entire sample, square pieces, each weighing one gm. (+ 10 per cent). For each
piece in such a manner that a square of approximately 5 cm. x 5 cm. is obtained.
Keep one of the folded test specimen between two glass plates and place 1 kg.
weight on the top for 10 minutes. Remove the weight. Lift the specimen with
forceps and gently place it on the surface of water (the specimen should be
lightly pinched in the middle with the blunt forceps having no serrations). As
soon as the specimen touches the water surface start a stop watch which is
stopped when the entire sample disappears below the surface of the water.
Record the time taken. Repeat the test with the other four-test specimens.
Calculate the average time in seconds.

Foreign Matter Dry about 5 g. of the sample to constant weight at 105°C

and weight the dried sample accurately. Extract the dried sample with
chloroform for one hour in an apparatus for the continuous extraction of drugs.
Remove the extracted sample to a beaker and allow the evaporation of residual
chloroform. Wash the material 12 times with hot water, using about 1000 ml.
for each washing and wringing the material by hand after each washing; pass all
water through a fine sieve (100 mesh.). Place the washed material and any loose
threads or fibres from the sieve in a beaker, cover with a 0.5 per cent aqueous
solution of diastase and maintain at 50°C until free from starch. Allow to cool,
filter the solution through a sieve; return sample and loose fibres to a beaker.
Repeat the washing process as before with hot water. Dry the material to
constant weight at 105°C, and determine the loss in weight. Calculate the
percentage of foreign matter, which is equal to the loss in weight, with reference
to the sample dried to constant weight, at 105°C.

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 If the sample is tested with iodine and is known to be free from starch, the
treatment with solution of diastase and the second series of washing with hot
water may be omitted.

Cloth for manufacture of Plaster of Paris Bandages, cut and uncut

Synonyms: Bleached Bandage Cloth for Plaster of Paris, Rolled Bandage for
Plaster of Paris.

Cloth for Plaster of Paris Bandages shall consist of cotton cloth of leno
weave made from yarn of suitable count. It may be supplied cut or uncut of
various widths and lengths.

Description (a) For uncut bandages Cotton cloth of leno weave, in one
continuous length showing no joints or seams, and with selvedges. The cloth is
bleached to a good white, is clean and odourless and reasonably free from
weaving defect as well as from seed and leaf debris; the cloth may be dressed if
necessary and if so, shall not dust off when unrolled.

(b) For cut bandages Same as for uncut bandages except for selvedges
which shall not be included and the bandages shall be cut evenly with straight
edges and be reasonably free from loose threads.

Threads per dm.

Warp Average not less than 150/dm.; and Weft average not less than
75/dm.

Weight in [Link].2 35 ± 5.

Length and Width The length and width for uncut bandages shall not be
less than 98 per cent each of the length and width stated. For cut bandages a
tolerance of ± 5 cm. in length and ± 0.5 cm. in width may be allowed, and each
of the bandages in packing complies these requirements.

Fluorescence When viewed under screened ultra violet light not more than
occasional points of fluorescence are observed.

Packing, Labelling and Storage Bandage Cloth for Plaster of Paris shall
be packed securely so as to allow normal handling and transport without tearing
and exposing the contents. In packages of cut and rolled bandages, each

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bandags shall also individually be wrapped in suitable paper. The package shall
be labelled as "Cloth for Plaster of Paris Bandage". The net content is stated on
the label in terms of number of rolls and length and width. Bandage Cloth for
Plaster of Paris must be stored in packed condition protected from dust.]
1102
[SCHEDULE F(III)

(See rule 124D)

STANDARD FOR UMBILICAL TAPES

(A) STANDARDS FOR STERILISED UMBILICAL POLYESTER

TAPE

Description A uniform strand of Polyester yam prepared by braiding and may

be finished with a suitable silicone finishing material, white to yellowish-white
in colour. Tape shall be sterilised by Gamma Radiation or by any other suitable
method approved by the Licensing Authority.

Other requirements The Umbilical Polyester Tape shall conform to the

claims made on the label in respect of length and width.

Tensile strength The Umbilical Polyester Tape shall have Tensile

strength of not less than 4 kgs. on straight pull.

Packing and labelling The Umbilical Polyester Tape shall be packed in

sealed Polythene bags or sealed plastic containers which ensure that when
packed, the tape is sterile. The packing shall protect the tape from
contamination and damage. Every packing offered for sale shall bear a clear and
permanent marking with the following particulars:

(i) The proper name of the drug i.e. Umbilical Polyester Tape 'Sterile'.

(ii) Manufacturer's name and address.

(iii) Batch Number.

(iv) Licence number under which the tape is manufactured.

(v) Date of manufacture and the date of expiry.

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