2009

In-process and Finished Product Quality

Control Tests for Surgical Products

Authors
M.B.Rahul Reddy
A. Shravya
I M. Pharm - Pharmaceutical Analysis

Editor
R.S.Bhat
Asst. Professor

JSS College of Pharmacy, Mysore

QC – Surgical Dressings Page 1
Introduction When such material without a needle is used
Surgical products can be mainly classified to stop bleeding by tying off several blood
into two vessels, the strand is called ligatures and the
1) Surgical dressings process is known as ligating.
2) Sutures
Composition
Surgical Dressings Cotton and linen were among the earliest
surgical dressing is a term applied to a wide suture materials but the use of animal
range of materials used for dressing wounds intestines is now mostly practiced.
or injured or diseased tissue.
ƒ Surgical dressings provide an Classification
environment for moist wound healing. There are mainly two types of sutures
ƒ Desiccation of a wound is a major factor 1) Absorbable sutures
in retarding wound healing and 2) Non absorbable sutures
increasing scarring. a) Synthetic non absorbable sutures
ƒ Dressing that prevent desiccation provide b) Metallic sutures
an optimal environment for autolysis, cell
migration granulation and 1) Absorbable sutures: absorbable are
reepithelialization. found those materials that are capable of
ƒ Protect the wound from further damage being broken down or digested by the
(mechanical damage, microbial invasion, body. Cat gut, the classic absorbable
dehydration, maceration, chemical suture derived from collagen rich animal
damage and alteration in PH). tissue, it is proteinaceous in nature and it
appears that certain proteolytic enzymes
Classification in tissue are responsible for the digestion
Functionally the simplest method of of catgut and its disappearance from the
classification uses the terms primary and wound area. Ex: surgical gut, synthetic
secondary dressings. A primary dressing absorbable sutures, corgile membrane
directly contacts the wound. It may provide and fascila lata.
absorption capacity and may prevent 2) Non absorbable sutures: non
desiccation, infection and adhesion of the absorbable sutures are manufactured
secondary dressing to the wound. There are from various materials such as polyester,
different type’s primary dressings: nylon or polypropylene. These materials
a) Plain gauze incite a minimum foreign body reaction
b) Impregnated gauze at the site of placement, which resolves
c) Film dressings over time.
A secondary dressing is placed over a Non absorbable sutures are used
primary dressing, providing further frequently for cardiovascular, ophthalmic
protection, absorptive capacity, compression, and Neurological procedures.
or occlusion. They are of different types of a) Synthetic non-absorbable sutures:
secondary dressing: ex- polester fiber
a) Absorbents b) Metallic sutures: ex- silver suture,
b) Bandages stain less steel suture.
c) Adhesives , tapes
d) Protective’s In process quality control and finished
product quality control tests
Conditioning of material for testing
The material to be tested for weights, area,
thread per stated length, tensile strength
and absorbency are unwrapped, opened out
and subjected to the regulated atmosphere
for not less than twenty four hours
immediately before testing, unless otherwise
stated and should be tested in the sample
Sutures atmosphere.
A surgical suture is a strand or fiber used to Regulated atmosphere: unless otherwise
hold wound edges in a position during stated, the regulated atmosphere is
healing and the process of applying such a controlled at 60% to 70% relative humidity
strand is called suturing. and at 18˚ to 22˚.

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The quality control tests performed are unless otherwise directed in the
(SDM- surgical dressing method) monograph.
1) Fiber Identification (SDM I) ii. Method 2: This method is also similar to
2) Yarn Number (SDM II) the above method but distance is 1cm.
3) Threads Per Stated Length (SDM III)
4) Weight Per Unit Area (SDM IV) b) Fully Stretched
5) Minimum Breakage Load (Tensile Determine the number of wrap threads when
Strength) (SDM V) the material is fully stretched by application
6) Elasticity (SDM VI) of a force of 10Ncm-1 , width about 1.07 cm-1
7) Extensibility (SDM VII) in the weft direction (horizontally).
8) Adhesiveness

1) Fiber Identification (SDM I)

a) Cotton fiber
i. When examined under a microscope,
each fiber is seen to consist of a
single cell, up to about 4cm long and
up to 40 µm wide, in the form of a
flattened tube with thick and rounded
walls and often twisted.
ii. Treated with iodinated zinc chloride
solution the fibers become violet.

b) Bright Viscose
Viscose is made from wood cellulose by
soaking in alkali and carbon disulphide,
4) Weight Per Unit Area (SDM IV) :
followed by precipitation of the cellulose in
A. Non- Adhesive Dressings
the form of a thread by forcing the solution
Determine the weight of the specimen being
of thread by forcing the solution of cellulose
examined (W g). Measure its un-stretched
through fine holes in a metal plate into a
width (a cm) and its fully stretched length (b
coagulation fluid.
cm). Calculate the weight per unit area in
i. When examined under a microscope, gm-2 from the expression.
the fibers are clearly visible in chloral
hydrate solution and lacto phenol,
almost invisible in cresol and invisible in
cresol. Ex: standard: for cellulose wadding weight
ii. Dissolve the residue obtained in the per unit area must be in between 425 to 550
test for sulphated ash in 5 ml of gm-2.
sulphuric acid with slight warming allow Ex: standard: for non adhesive dressings
to cool and add 0.2ml of hydrogen weight per unit area not less than 84 gm-2
peroxide solution the solution does not
become orange yellow B. Adhesive Dressings
2) Yarn Number (SDM II) Determine the weight of the specimen being
Yarns numbered in the Tex system. The Tex examined (Wg). Measure its width and
number is the weight in g of 1000 m of yarn. length and calculate its total area (Am2). Cut
In the British pharmacopoeia the yarn out rectangular full width samples, each
numbers are rounded up to the nearest Tex. weighing 3g to 4g from three positions
approximately equidistant along the length
3) Threads Per Stated Length (SDM III) of the specimen, combine the samples and
a) Unstretched: weigh accurately (wg). Macerate the
i. Method 1: Determine the number of combined samples with successive 250ml
threads over a distance of 2.5 cm by quantities of chloroform or other suitable
means of a suitable instrument. If the solvent until the adhesive mass appears to
size or number of units available permits have been removed decant each extract
repeat the determination at not less than through a sieve with a nominal mesh
four other independent positions selected aperture to 106 µm, and return any fibers
as being representative of the material retained by the sieve to the bulk of the
being examined and calculate the fabric.
average number of threads per 10cm,
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Cover the extracted fabric with a 50% v/v Apply gradually to the movable grip a force
solution of acetic acid and allow to stand of 10 Ncm-1 width (1.0 kg f cm-1 width)
until all of the zinc oxide retained in the ensure that the full load is applied within five
fabric has dissolved. Decant the liquid and seconds from starting to stretch. Measure
wash the fabric with successive quantities of the length of the material between the
water until the washings are free from marks, to the nearest cm, as soon as the full
acidity fibers retained by the sieve to the load is applied (S cm).
bulk of the fabric.
Maintain the load for a total stretching time
Dry the extracted fabric at 105°, recondition of fifty five to sixty five seconds, ensuring
it by subjecting it to the regulated that at no time the load is exceeded and
atmosphere for twenty four hours, and then release the tension as rapidly as
determine its weight (f g). possible without allowing the material to
Calculate the weight per unit area, in gm-2, tangle. Remove the material from the grips,
from the expression loosely fold the whole length in a zig zag
with folds of 15 to 20 cm, and allow the
material to relax for 4.75 to 5.5 minutes
from the time of release of the tension. In
the case of adhesive material, fold it edge to
5) Minimum Breakage Load (SDM V)
edge along its length with the adhesive
(Tensile strength)
surface inner most before removing the
Prepare five strips of the material to be
material between the marks, to the nearest
examined as representative of the sample as
cm (r cm).
possible, each 200mm in length and of
known widths not greater than 25nm (or cut
Calculate the fully stretched length and the
longitudinally to get strips of that width) so
regain length from the following expressions:
that both surfaces are freely accessible to
the regulated atmosphere for 24 hours
preceding the test. Determine the breakage
load of each strip using a traverse machine
having a movable grip with a speed of 270 to
330mm per minute and a capacity such that
when the specimen breaks the reading
obtained is between 15% and 85% of the full Repeat the procedure on another sample and
scale deflection. Place one end of the strip in calculate the average value.
the fixed grip and the other in the movable
grip in such a way that the distance w 7) Extensibility (SDM VII)
between the grips is 100mm. any strip which Carry out the tests on a constant rate
slips during the test, or breaks within 10mm tranverse machine. Test six representative
of the grips, should be excluded and specimens of the sample each at least
replaced by another strip. Repeat the 100mm long, and as representative as
procedure on the other four specimens and possible of the sample, and calculate the
calculate the average values. average result.

6) Elasticity
Measure the length of the material in the
unstretched condition (L cm). Place one end
of the material in a fixed grip and the other
in a movable grip of a spring dynamometer
or other suitable device in such a way that
the ends of the material stretches in the
elastic direction.
Ensure that the ends of the
materials are securely held for
example by means of pins in the
Determine the load required to produce a
grips to minimize any slip while
20% extension at a rate of extension of 270
the materials are under tension.
to 330mm per minute, the load is not more
Mark the material between the
than 14 Ncm-1 width (about 1.4 kgfcm-1
grips at points approximately
width).
50cm apart (l cm).

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Maintain the 20% extension of the material The top edge of the strip attached to the
for 55 to 65 seconds; allow recover for 4.75 plate dose not slip by more than 2.5 mm
to 5.25 minutes and redetermine the length; during the period in the oven.
the permanent set of the elongated material
is not more than 5 percent of the original Quality control tests for surgical gut or
length. cat gut
• Length
8) Adhesiveness (SDM VIII)
Apparatus: stainless steel plate, roller. • Diameter
Procedure: Condition the roll or sheet of • Minimum breaking load
plaster or tape for 24 hours before the test.
For plasters or tapes in the form of strips, • Soluble chromonium compounds
unwind from the roll at a speed of • Strength of needle attachment
approximately 30cm s-1 immediately before
testing and cut off a piece about60mm long. • Extractable colour (if suture is dyed)
If the specimen is not more than 25mm • Sterility tests
wide, use the whole width if it is more than
25mm wide carry out the test on strips 25 Length
mm wide cut from the specimen. Measure the length without applying to the
suture more tension than is necessary to
For plasters or tapes in the form of sheets,
keep it straight. The length of each suture is
remove the protective covering immediately
not less than 90 per cent of the length stated
before testing and cut a piece of the plaster
on the label and does not exceed 350 cm.
or adhesive tape of appropriate dimensions.
Take care not to contaminate the adhesive
Diameter
surface during the test.
Carry out the test on 5 sutures.
Bring the adhesive side of one end of the
prepared strip into contact with the cleaned Use a suitable mechanical instrument of the
surface of the stainless steel plate in such a dial reading micrometer capable of
manner that the whole width of the strip is measuring with an accuracy of at least 0.002
attached to the plate for a distance of 25 mm and having a circular pressor foot 10
mm from one end, with the sides of the strip mm to 15 mm in diameter.
parallel to the longer sides of the plate, and The pressor foot and the moving parts
the unattached portion of the strip attached to it are weighted so as to apply a
overhanging the end of the plate. When total load of 100 ± 10 g to the suture being
attaching the strip ensure that no air bubble tested. When making the measurement,
are trapped between the strip and the plate. lower the pressor foot slowly to avoid
Apply pressure to the attached portion of the crushing the suture.
strip and the plate. Apply pressure to the
Measure the diameter at intervals of 30 cm
attached portion of the strip by means of the
over the whole length of the suture.
roller, making four passages along the length
of the strip at a speed of about 60cm per For a suture less than 90 cm in length,
minute, and allow to stand in the regulated measure at 3 points approximately evenly
atmosphere for ten minutes. Mark on the spaced along the suture.
plate the line of the end of the strip. The suture is not subjected to more tension
Attach a weight equivalent to 80g cm-1 width than is necessary to keep it straight during
of the strip to the free end of the strip by measurement.
means of a stirrup so that the load is evenly
The average of the measurements carried
distributed across the width of the strip.
out on the sutures being tested and not less
Suspend the plate in a hot air oven fitted
than two-thirds of the measurements taken
with a device for circulating air at 36° to 38°
on each suture are within the limits given in
for thirty minutes, in such a manner that the
the columns under ‘A’ in Table 1 for the
plate is inclined at an angle of 2° from the
gauge number concerned.
vertical in a direction which prevents the
strip peeling from the plate, and the weight None of the measurements is outside the
is hanging freely. Repeat the procedure on a limits given in the columns under ‘B’ in Table
further four strips. 1 for the gauge number concerned.

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Minimum breaking load
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 (see Fig.1 and pulling the
knot tight). Carry out the test on 5 sutures.
Submit sutures of length greater than 75 cm
to two measurements and shorter sutures to
one measurement.
Determine the breaking load using a suitable
tensilometer. Soluble chromium compounds
The apparatus has 2 clamps for holding the Place 0.25 g in a conical flask containing 1ml
suture, one of which is mobile and is driven of water per 10 mg of catgut. Stopper the
at a constant rate of 30 cm/min. The clamps flask, allow to stand at 37 ± 0.5 ° C for 24 h,
are designed so that the suture being tested cool and decanting the liquid. Transfer 5 ml
can be attached without any possibility of to a small test tube and add 2 ml of a 10 g/l
slipping. At the beginning of the test the solution of diphenylcarbazide in alcohol and
length of suture between the clamps is 12.5 2 ml of dilute sulphuric acid.
cm to 20 cm and the knot is midway The solution is not more intensely coloured
between the clamps. Set the mobile clamp in than a standard prepared at the same time
motion and note the force required to break using 5 ml of a solution containing 2.83 µg of
the suture. If the suture breaks in a clamp or potassium dichromate per millilitre, 2 ml of
within 1 cm of it, the result is discarded and dilute sulphuric acid and 2 ml of a 10 g/l
the test repeated on another suture. solution of diphenylcarbazide in alcohol
The average of all the results, excluding (1ppm of Cr).
those legitimately discarded, is equal to or Strength of Needle attachment
greater than the value given in column C in If the catgut is supplied with an eyeless
Table 1 and no individual result is less than needle attached that is not stated to be
that given in column ‘D’ for the gauge detachable, it complies with the test for
number concerned. needle attachment.

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Carry out the test on 5 sutures. 4. Minimum breaking load
Use a suitable tensilometer, such as that 5. Strength of needle attachment
described for the determination of the 6. Abnormal toxicity
minimum breaking load. Abnormal toxicity
Fix the needle and suture (without knot) in ƒ Insert into the skin of the backs of each
the clamps of the apparatus in such a way five guinea pigs a piece of strand 1cm
that the swaged part of the needle is long.
completely free of the clamp and in line with
ƒ Fifteen days after insertion the animals
the direction of pull on the suture.
show only normal reactions of initial
Set the mobile clamp in motion and note the absorption and no undue histological
force required to break the suture or to lesions or other symptoms appear.
detach it from the needle.
ƒ If not more than one animal shows
The average of the 5 determinations and all abnormal reactions the sutures fail the
individual values are not less than the test.
respective values given in Table 2 for the
gauge number concerned. Synthetic absorbable sutures and
If not more than one individual value fails to ligatures
meet the individual requirement, repeat the Polymers derived from condensing the cyclic
test on an additional 10 sutures. derivative of glycolic acid (glycolide),
mixture of glycolide and lactide (derived by
The catgut complies with the test if none of
cyclising lactic acid), diaxanone, glycolide
these 10 values is less than the individual
with trimethylene carbonate and diaxanone
value in Table 2 for the gauge number
showed that make processes suitable for
concerned.
many surgical procedures.
Dexon II a polyglycolic acid homopolymer
and Vicryl and Polysorb glycolide and lactide
copolymers are melt extruded into
multifilament yarns and then are and then
are braided into various sized. Such braids
have high tensile strength and must be
packed without fluid and sterilized with
ethylene oxide to avoid degradation.
Synthetic absorbable sutures do not undergo
enzymically mediated absorption process
rather the suture is broken down completely
by simple bulk hydrolysis as it resides in the
tissue and the tissue reaction is minimal.
Cargile membrane
Other tests This is a thin sheet of pliable tissue obtained
• Extractable colour (if suture is dyed) from the appendix of the steer or ox.
• Sterility tests It is designed primarily to cover surfaces
from which the peritoneum has been
Reconstituted collagen suture removed especially where a sterile
membrane would lessen the formation of
Reconstituted collagen suture is made from
adhesions. The membrane is available in
the collagen of healthy mammals, usually sterile sheets and is sometimes used as a
from muscle tendons, by extraction and packing or protective sheath.
resolidification of the material and subjecting
Fascia lata
the strands so obtained to a sterilisation This is obtained from ox fascia and is used
procedure. for a heavy suture or repair in hernia or
similar cases.
Tests
1. Sterility Non absorbable surgical sutures
2. Length Non absorbable surgical suture is a flexible
3. Diameter strand of material that suitably resistant of
to the action of the living mammalian tissue.
QC – Surgical Dressings Page 7
It may be either monofilament or abdominal and inguinal hernia repair
multifilament. If it is a multifilament strand, procedures.
the individual filaments may be combined by
Other suturing techniques
spinning, twisting, braiding or any
Surgical stapling devices are available that
combination.
automatically approximate tissues with rows
It may be modified with respect to body, to steel staples.
texture, or to reduce capillarity, and is
Such devices exist for closing skin and
suitably bleached. It is impregnated or
anatomising blood vessels as well as for
treated with a suitable coating, softening, or
reconstructing other organs such as stomach
antimicrobial agent. It may be coloured by
and intestine.
an approved colouring agent.
Some surgical staples are designed to cut
Non absorbable sutures are the strands
tissues before and after the staples are
when introduced into the living organism are
applied.
not metabolised by that organism.
V-shaped steel, tantalum or titanium clips
Appropriate harmonised standards may be
have been used to clamp small blood
considered when assessing compliance with
vessels.
respect to origin and processing of raw
materials and with respect to Ligating clips are represented by absorbable
biocompatibility. materials, polydoxanone and lactomer.
Sterile non-absorbable surgical sutures serve Ligating clips made from these substances
to approximate tissue during the healing absorb after the function is completed and
period and provide continuing wound do not remain permanently in the patient as
support. do the metallic clips.
Non absorbable sutures are classified as Quality control tests
follows • Sterility tests
Class I
It is composed of silk and synthetic fibers of • Length
monofilament, twisted or braided • Diameter
construction it does not affect the thickness.
• Minimum breaking load
Class II
Composed of cotton or linen fibers or coated • Strength of needle attachment
natural or synthetic. Coating significantly • Extractable colour
affects thickness, but does not contribute
significantly to strength. Tests
Remove the sutures from the sachet and
Silk (Filum bombycis) measure promptly and in succession the
Sterile braided silk suture is obtained by length, diameter and minimum load.
braiding a number of threads, according to
the diameter required, of degummed silk If linen is tested the sutures are conditioned
obtained from the cocoons of the silkworm as follows: if stored in the dry state, expose
Bombyx mori. to an atmosphere with a relative humidity of
65 ± 5 per cent at 20 ± 2 °C for 4 h
Identification of silk immediately before measuring the diameter
A. Dissect the end of a suture, using a and for the determination of minimum
needle or fine tweezers, to isolate a few breaking load immerse in water R at room
individual fibres. temperature for 30 min immediately before
carrying out the test.
B. Impregnate isolated fibres with iodinated
potassium iodide solution. The fibres are Length
coloured pale yellow. Measure the length without applying more
tension than is necessary to keep them
Surgical meshes straight.
Surgical meshes are used in reinforcement The length of the suture is not less than 95
material to aid in tissue repair and per cent of the length stated on the label and
encourage in growth of fibrous connective does not exceed 400 cm.
tissue. Meshes are used for umbilical,

QC – Surgical Dressings Page 8

Diameter Storage (Packaging)
Sterile non-absorbable and sutures are
presented in a suitable sachet that maintains
sterility and allows the withdrawal and use of
a suture in aseptic conditions. They may be
stored dry or in a preserving liquid to which
an antimicrobial agent but no antibiotic may
be added.
Sterile non-absorbable sutures are intended
to be used only on the occasion when the
sachet is first opened.
Sutures in their individual sachets (primary
packaging) are kept in a protective cover
(box) which maintains the physical and
mechanical properties until the time of use.
The application of appropriate harmonised
standards for packaging of medical devices
Extractable colour shall be considered in addition.
Sutures that are dyed and intended to
remain so during use should comply with the Labelling
test for extractable colour. Place 0.25 g of Reference may be made to the appropriate
the suture to be examined in a conical flask, harmonised standards for the labelling of
add 25.0 ml of water and cover the mouth of medical devices.
the flask with a short-stemmed funnel. Boil
for 15 min, cool and adjust to the original The details strictly necessary for the user to
volume with water. Depending on the colour identify the product properly are indicated on
of the suture, prepare the appropriate or in each sachet (primary packaging) and
reference solution as described in the on the protective cover (box) and include at
following Table using the primary colour least:
solutions. ƒ gauge number
ƒ length, in centimeters or meters
ƒ if appropriate, that the needle is
detachable
ƒ name of the product
ƒ intended use (surgical suture, absorbable
and non-absorbable)
ƒ if appropriate, that the suture is coloured

The test solution is not more intensely ƒ if appropriate, the structure (braided,
coloured than the appropriate reference monofilament, sheathed).
solution.

Monomer and oligomers References

Polyamide-6 suture additionally complies
with the following test for monomer and 1. British Pharmacopoeia 1980, page no:
oligomers. 903.
In a continuous-extraction apparatus, treat 2. USP, page no: 1930,1938 and 1584.
1.00 g with 30 ml of methanol R at a rate of
at least 3 extractions per hour for 7 h. 3. Tutorial Pharmacy by Cooper and Gunn
Evaporate the extract to dryness, dry the 4. Remington; The science and practice of
residue at 110°C for 10 min, allow to cool in pharmacy, Vol 2, page no:1974-1978
a desiccator and weigh. The residue weighs
not more 20mg (2 per cent).

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