Quality control test for surgical products

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Quality Control Test for Surgical
Products
A Seminar as a part of curricular requirement
for I year M. Pharm I semester
Presented by
G. Sateesh Chandra
(Reg. No. 20L81S0711)
Under the guidance/Mentorship of
Dr. K. Vinod Kumar, M. Pharm, Ph. D.,
Professor and Head,
Dept. of Pharmaceutical Analysis

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• Introduction
• Surgical dressing
• Classification of Surgical dressings
1. Cotton
2. Wool
3. Fibers
4. Rubber and Oil impregnated materials
• Surgical Sutures
• Quality Control test for sutures
• References
Contents

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Introduction
• Surgical products are materials used for surgery to diagnose, prevent
or for the treatment of disease or other injury conditions.
• Such products should not show chemical action with the body or
physiology of the patients.
• Some of the surgical products are:
Forceps
Scissors
Surgical dressings
i. Cotton
ii. Gauge

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Iv. Bandages
v. Adhesive tapes
Gloves
Needles/ Syringes
IV Cannula
Catheters

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Surgical dressing is a term applied to a wide range of materials used
for dressing wounds or diseased tissue.
The main purpose of surgical dressing is to protect the wound from:
• Further damage
• Mechanical damage
• Microbial invasion
• Dehydration
• Maceration
• Chemical damage
• Alteration in pH
SURGICAL DRESSINGS

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1. Based on Function:
• Primary Dressing:- They come in direct contact with the wound.
Ex: Plain gauze, Impregnated gauze, Film dressing
• Secondary Dressing:- They are placed over the primary dressing.
Ex: Adsorbents, Bandages, Adhesive tapes
Classification of Surgical Dressings

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• Cotton consists of the epidermal trichomes of the seeds of
Gossypium herbaceum and other cultivated species of gossypium.
• TESTS:
Identification Test:
1. COTTON
Moisten with iodine when nearly dry
Add 80% of Sulphuric Acid
Blue colour

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Foreign fiber Test:
Examined under microscope, it is seen to consist exclusively of typical cotton
fibers, except that occasionally a few isolated foreign fibers may be present.
Fluorescence:
Examine a layer under UV light at 365nm
It displays only slight brownish-violet
fluorescence and few yellow particles

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Absorbency:
Weigh basket (m1)
Take total sample from 5 different places and place loosely in the basket &
weigh the filled basket (m2)
Fill the beaker with water at 10℃
Hold the basket horizontally and drop it from the top into the water
Measure the time for sinking & calculate result by 3 tests
Remove the basket from water, allow it to drain and weigh (m3)
Transfer it to tared beaker and weigh (m4)

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Tests:
Sample + ZnCl solution
Violet colour
Heat at 40℃
Allow to stand for 2.5 hrs,
shake occasionally
Dissolves completely

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FINISHED PRODUCT TESTING:-
Foreign fibers
Fluorescence
Absorbency
Surface Active Substances

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• It is prepared from the fleece of the sheep (ovies aries) by cleaning
and washing
• In Process Tests: Test procedures are same as done for cotton.
FINISHED PRODUCT TESTING:-
• Ammoniacal CuO:
2. WOOL
separation of the scales, colours
the fibers into blue
Wool + Ammonical CuO

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• Lead Acetate:
• Solubility:
It is not soluble in warm HCL or cold concentrated H2SO4 but it is
soluble at 100ºc in 4 to 5% solution of sodium hydroxide.
solution of wool in caustic soda + lead acetate
Black precipitate will form due to the high Sulphur content

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Surgical dressing is woven from yarn of cotton, wool or silk and is
usually of plain weave, the material should be of good quality and
free from foreign matter as possible.
STANDARDS: Specified areas of fabric lengths of components yarns.
Weighing must be done under standard condition of humidity.
The material must prior to such weighing, be exposed to an
atmosphere of 63 -67 % relative humidity at 18ºc to 25ºc for at last
6hrs.
3. FIBRES

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FINISHED PRODUCT TESTS:
• Count: The count of yarn is the number of hanks, each of specified length,
in one pound, and it is a measure of its fitness.
• Threads per inch:
o For fabrics of fairy close texture, the no. of threads in one linear inch is
measured by means of a linen tester.
o It is placed on smooth fabric with the sides parallel to the wrap and weft
threads, the no of threads per linear inch may be readily counted.
o For more open fabrics a length of 10 inches is counted to increase
accuracy. This standard is applied to all fabrics weight.

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• Weight:
o A specified area of fabrics should have a definite weight. This is a
simple check on the fillers. Count of the yarn used.
oIn case of plasters and adhesive bandages this is done by extracting
with chloroform or other suitable solvent in continuous extraction
apparatus until the adhesive mass completely dissolved.
• Tensile strength:
It is the measure of load necessary to rupture the fabric and is carried
out by means of dead

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• Foreign Matter:
o Tallow oils & fats are extracted in a continuous extraction apparatus,
using an organic solvent like ether, chloroform etc.
o After evaporate the solvent, soluble salts are removed by washing in
hot running water.
o Starch present is removed by digestion at 70º C with 0-5 % solution
of malt extract, then starch is washed out by water.
o Loosen threads and fibers on fine sieve dried at 100º C & weigh.
o Loss in weight is foreign matter.

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• Water Soluble Extractive:
o This test is carried out on the dried sample, by washing out foreign
matter in the same way described under “foreign- matter” taking
care to collect loosened fibers on a fine sieve and finally dry at 100ºC
and weighing.
• Absorbency: Like absorbent cotton.

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Non-adhesive Dressing:- They are generally fine mesh gauze
supplemented with substances to augment its occlusive properties
or antibacterial abilities.
E.g.- Soft silicone, soft polymer, knitted polyester.
• Rubber coated: The fabric must comply the usual FABRIC STANDARD.
• Additional standard: weight of water proofing material. Limit of
mineral matter in the proofing. When boiled for 30min or autoclave
for 20 mins at a pressure of 15lb per square inch, it should not be
sticky or deteriorate.
4. RUBBER AND OIL IMPREGNATED
MATERIALS

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• Oil coated: In each of these dressing the fabric, which is of plain
weave, is made water proof by treatment with drying oil or oil
modified synthetic resins. Which produce non- adhesive dressing
Adhesive Dressing:
E.g.: Self – Adhesive rubber plaster
Zinc oxide self – adhesive plaster
Zinc oxide elastic self - adhesive plaster.

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A surgical suture is a strand or fiber used to hold wound edges
in a position during healing and the process of applying such a
strand is called suturing.
Suture is a strand of any material used for
 Ligating Blood vessels
 Transfixing
 Approximating tissues
SURGICAL SUTURES

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PRETREATMENT:
o If stored in a preserving liquid, remove the sutures from the sachet and
measure promptly and in succession the length, diameter and breaking
load.
o If stored in the dry state, immerse the sutures in alcohol or a 90 per cent
V/V solution of 2-propanol for 24 h and proceed with the measurements as
indicated below.
Quality Control Tests for Sutures

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Length:
• Measure the length by not applying more tension to the suture than
is necessary to keep it straight.
• Acceptance criteria:
i. As per B.P: The length of each suture is not less than 90 % of the
length stated on the label and does not exceed 350 cm.
ii. As per USP: The length of each strand in not less than 95% of the
length stated on the label.

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Diameter:
o Carry out the test on 5 sutures.
oUse a suitable instrument capable of measuring with an accuracy of
at least 0.002 mm and having a circular pressor foot 10 mm to 15
mm in diameter.
o The pressor foot and the moving parts
attached to it are weighted so as to
apply a total load of 100 ± 10 g to the
suture being tested.
o When making the measurement, lower
the pressor foot slowly to avoid
crushing the suture.

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o Measure the diameter at intervals of 30 cm over the whole length of the
suture.
o For a suture less than 90 cm in length, measure at 3 points approximately
evenly spaced along the suture.
o The suture is not subjected to more tension than is necessary to keep it
straight during measurement.
• Acceptance criteria (As per BP):
o The average of the measurements carried out on the sutures being tested
and not less than two-thirds of the measurements taken on each suture
are within the limits given in the columns under A in Table for the gauge
number concerned.
o None of the measurements is outside the limits given in the columns under
B in Table for the gauge number concerned

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• Acceptance Criteria (As per USP):

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Minimum breaking load:
o The minimum breaking load is determined over a simple knot formed by
placing one end of a suture held in the right hand over the other end held
in the left hand, passing one end over the suture and through the loop so
formed and pulling the knot tight.
o Carry out the test on 5 sutures.
Submit sutures of length greater
than 75 cm to 2 measurements and
shorter sutures to one
measurement.
o Determine the breaking load using
a suitable tensiometer.

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o The apparatus has 2 clamps for holding the suture, one of which is mobile
and is driven at a constant rate of 30 cm/min.
o The clamps are designed so that the suture being tested can be attached
without any possibility of slipping.
o At the beginning of the test the length of suture between the clamps is
12.5 cm to 20 cm and the knot is midway between the clamps.
o Set the mobile clamp in motion and note the force required to break the
suture.
o If the suture breaks in a clamp or within 1 cm of it, the result is discarded
and the test repeated on another suture.

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• Acceptance criteria (As per BP):
The average of all the results, excluding those legitimately discarded, is
equal to or greater than the value given in column C in Table and no
individual result is less than that given in column D for the gauge
number concerned

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oDetermine the tensile strength on not fewer than 10 strands of
suture.
oThe tensile strength, determine as the minimum strength for each
individual strand tested, and calculated as the average strength from
any one lot, is set forth in table.
oIf not more than one strand fails to meet the limit on individual
strands repeat the test with not less than 20 additional strands: the
requirements of the test are met if none of the additional strands
falls below the limit on individual strands, and if the average
strength of all the strands does not fall below the stated limit in
table.

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Soluble chromium compounds:
o Place 0.25 g in a conical flask containing 1 ml of water per 10 mg of catgut.
Stopper the flask, allow to stand at 37 ± 0.5 °C for 24 h, cool and decant
the liquid.
o Transfer 5 ml to a small test tube and add 2 ml of a 10 g/l solution of
diphenylcarbazide in alcohol and 2 ml of dilute sulphuric acid.
o Acceptance criteria:
The solution is not more intensely coloured than a standard prepared at the
same time using 5 ml of a solution containing 2.83 μg of potassium
dichromate per millilitre, 2 ml of dilute sulphuric acid and 2 ml of a 10 g/l
solution of diphenylcarbazide in alcohol (1 ppm of Cr).

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Needle attachment:
o If the catgut is supplied with an eyeless needle attached that is not stated
to be detachable, it complies with the test for needle attachment.
o Carry out the test on 5 sutures. Use a suitable tensiometer, such as that
described for the determination of the minimum breaking load.
o Fix the needle and suture (without knot) in the clamps of the apparatus in
such a way that the swaged part of the needle is completely free of the
clamp and in line with the direction of pull on the suture.
o Set the mobile clamp in motion and note the force required to break the
suture or to detach it from the needle.

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• Acceptance criteria (As per B.P):
o The average of the 5 determinations and all individual values are not
less than the respective values given in Table for the gauge number
concerned.
o If not more than one individual value fails to meet the individual
requirement, repeat the test on an additional 10 sutures.
oThe catgut complies with the test if none of these 10 values is less
than the individual value in Table for the gauge number concerned.

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o The requirements are met if neither the average of the 5 values nor
any individual value is less than the limit given in the designated size
in table.

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Extractable color:
 Prepare the matching solution that corresponds to the extractable color of
the suture by combining the colorimetric solutions in the proportions
indicated in table and adding water, if necessary, to make 10.0 parts
 Weigh a quantity of suture, equivalent to not less than 250mg, and place in
the conical flask containing 1 ml of water for each 10mg of the sample.
 Close the flask and allow it to stand at 37± 0.5ºC for 24 hours.
 Cool, decant the water from the suture, and compare with the matching
solution: any color present is not more intense than that of the appropriate
matching solution passes this test

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Catgut and other surgical sutures sterility test:
• Soya-bean casein digest medium is prepared or equivalent commercial
media may be used provided that they comply with the growth
promotion test.
• Soya-bean casein digest medium is to be incubated at 20-25 °C.
• Membrane filtration:
o After transferring the contents of the container or containers to be tested
to the membrane and filter
o To the filtrate add an inoculum of a small number of viable micro-
organisms(not more than 100 CFU) to the final portion of sterile diluents
used to rinse the filter.

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• Direct inoculation:
After transferring the contents of the container or containers to be
tested (for catgut and other surgical sutures for veterinary use:
strands) to the culture medium add an inoculums of a small number
of viable micro-organisms (not more than 100 CFU) to the medium.
• Procedure
o Carry out the test on 3 sections, each 30 cm long, cut off from
the beginning, the centre and the end of the strand.
o Inoculate the medium and keep for incubating. Incubate the sample
for 14 days. Keep two controls simultaneously for incubation.

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o Observe for microbial growth. Compare the results with both
negative and positive controls examine the media for
macroscopic evidence of microbial growth.
Acceptance criteria:
o The sample should inhibit the microbial growth

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• The theory and practice of industrial pharmacy second edition page
no: 260-272
• Gilbert. S. banker, Modern pharmaceutics, page: 577-579.
• Published on behalf of medicines and health care products
regulatory agency, the department of health, social services and
public safety, British Pharmacopoeia 2009, Volume III, page: 7877
• United states of pharmacopeia 30 national formulary 25, 2007, page:
374-376.
References

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