NONABSORBABLE SURGICAL SUTURES

 WELCOME TO THE STUDY

SESSION ON
NONABSORBABLE
SURGICAL SUTURES

 SCOPE:
TO GIVE BASIC
KNOWLEDGE ABOUT
NONABSORBABLE
SURGICAL SUTURES

 THIS TRAINING PROGRAM IS

USEFUL TO EMPLOYEES IN
PRODUCTION, Q.C AND
MARKETING DEPTS.
What is a suture? How does a Nonabsorbable suture differ
from an Absorbable suture?

 Suture is a strand or thread, used to ligate (tie) blood vessels or to

approximate (sew) tissues together.

 When the thread is used to tie the blood vessels, it is called

“ligature” and when it is used to sew the tissues, it is called
“suture”

 Absorbable sutures get digested or absorbed at the site of

implantation by proteolysis or by hydrolysis of the suture material
into it’s simpler structure whereas nonabsorbable sutures do not
get degraded at all (Polypropylene and Polyester) or get degraded
very slowly over a period of time (Nylon and Silk) but does not get
absorbed except Silk.
Characteristics of an ideal Nonabsorbable suture

 (1) Uniform in diameter throughout it’s length

 (2) Consistent tensile strength to the full length
 (3) Easy pliability
 (4) Good knot security
 (5) Less memory
 (6) Guaranteed sterility
 (7) Tissue acceptance (free of any irritating substances
and hence absence of tissue reaction)
 (8) Predictable performance in retention of tensile
strength when implanted in the body tissues
(9) Ready to use
 (10) Economical
NONABSORBABLE SURGICAL SUTURES (SIPL)

 GROUP 1 (MONOFILAMENT SUTURES)


1. TRULENE (MONOFILAMENT POLYPROPYLENE)
 2. TRULON (MONOFILAMENT POLYAMIDE)

 GROUP 2 (MULTIFILAMENT SUTURES)

 1. TRUSILK (BLACK BRAIDED SILK)
 2. TRUBOND (COATED POLYESTER)

 GROUP 3 (METALLIC SUTURES)

 1. TRUSTEEL (MONOFILAMENT STAINLESS STEEL)
 Flow chart for the manufacture of
Non absorbable sutures in Tyvek /Poly film Pack

Frame Winding Swaging

Over wrap Winding in Pre

Sealing printed folders

Gas sterilization Final packing

 Packing materials used for
Nonabsorbable sutures

 Nonabsorbable sutures are packed using Tyvek film /

Coated Tyvek or Medical grade paper and Poly laminated
Polyester film.

 There are a few customers like Unicef, Denmark, in

exports trade who buy the Nonabsorbable sutures range
of products in Al/Al/ foil packing.

 The sterile packs are then packed in boxes made of

Cyber Excel board. The boxes in 12’s or 36’s are wrapped
with shrink wrap film to avoid contamination of dust,
entry of insects and to preserve the boxes from moisture
 TYVEK FOIL / COATED TYVEK FOIL

 Tyvek foil is produced using fine fibres of 100% high density

Polyethylene (HDPE). These fine fibres with an average
diameter of 4 microns are flashspun, then laid as a web on a
moving belt and bonded together applying heat and pressure.

 Tyvek foil has the characteristics of paper, Polyfilm and cloth. It

is supplied in 762 mm width. Tyvek is the brand name of
DUPONT, the foil is supplied by Amcor Flexibles.

 Coated Tyvek is coated with a lacquer to give perfect sealing

with Poly coated Polyester film. It gives a clean peel, avoiding
shedding of fibres while tearing the pouch at the time of use.
 Important features of TYVEK
 1. Superior Tear strength
 2. Resistant to Microbial penetration
(Guarantees sterility for more than five years if stored properly)
 3. Excellent Puncture Resistance
(Can be Used to pack devices with sharp edges)
 4. Non inflammable (When fired, it melts without catching fire)
 5. Clean Peel (Does not shed fibres or particles)
 6. Light weight, yet strong (Reduces shipping bill considerably)
(Eight times stronger than Medical grade paper foil)
 7. Gas permeable (Suitable for E.O. sterilized products)
 8. Water and Chemical resistant (When put inside water, it does not
become wet
 9. Smooth and opaque. (Suitable for Gamma radiation sterilization)
 10. Resistant to sunlight. (Does not fade over any period of time)
 11. Low Bio burden.
 12. Re – cyclable (can be re - cycled at the local facilities that accept
Poly ethylene wastes).
 13. Compatibility with broad range of sterilization methods.
 14. Printing / stamping is possible
 15. Most commonly used for medical devices.
 Product specifications for
Nonabsorbable surgical sutures as per USP 32nd Edition
 Length:
 Length of each strand is not less than 95% of the length stated on the label.

 Diameter:
 Average Diameter and the individual diameter readings of the sutures should
pass for U.S.P. requirements for the particular size

 Needle Attachment Strength:

 Average needle attachment strength and the individual readings should comply to
U.S.P. requirements.

 Tensile strength:
 Average needle attachment strength and the individual readings should comply to
U.S.P. requirements.

 Extractable color test:

 Weigh approximately 250 mg of the suture and place in a conical flask containing
25ml of water. Close the flask , and allow it to stand at 37 +/- 0.5° C for 24 hours.
Cool, decant the water from the suture, and compare it with the matching
solution.
 Any color, present is not more intense than that of the appropriate matching
solution.

 Sterility Test: This test is done as per U.S.P. test method and the product should
pass this test.
 Diameter requirements for
Nonabsorbable surgical sutures
(U.S.P. SIZES / METRIC SIZES )

 U.S.P. METRIC
SIZE SIZE DIAMETER RANGE
3 6 0.600 To 0.699
2 5 0.500 To 0.599
1 4 0.400 To 0.499
0 3.5 0.350 To 0.399
2-0 3 0.300 To 0.339
3-0 2 0.200 To 0.249
4-0 1.5 0.150 To 0.199
5-0 1 0.100 To 0.149
6-0 0.5 0.050 To 0.099
7-0 0.4 0.040 To 0.049
8-0 0.2 0.020 To 0.039
 TENSILE STRENGTH AND NEEDLE - ATTACHMENT STRENGTH
REQUIREMENTS (NONABSORBABLE SUTURES)

U.S.P. AVERAGE AVERAGE T.S. N.A.S. N.A.S.

SIZE T.S NON STERILE AVERAGE MINIMUM
3 4.88 6.10 1.80 0.70
2 3.52 4.40 1.80 0.70
1 2.72 3.40 1.80 0.60
0 2.16 2.70 1.50 0.45
2-0 1.44 1.80 1.10 0.45
3-0 0.96 1.20 0.68 0.34
4-0 0.60 0.75 0.45 0.23
5-0 0.40 0.50 0.23 0.11
6-0 0.20 0.25 0.17 0.08
7-0 0.11 0.14 0.08 0.04
8-0 0.06 0.075 0.05 0.025
 Additional tests done for
Nonabsorbable sutures in Outside testing laboratory

 Residues of E.O. Sterilization, which includes

free E.O., Ethylene Chlor hydrin and Ethylene Glycol –
Limit: not to exceed 20 PPM each
 In vitro cyto toxicity test
 Bio Compatibility test: (Skin irritation study and Maximization
sensitization study)
 Monofilament sutures X Multifilament sutures
 Monofilament sutures are single filament sutures. (Example: Trulon).
Multifilament sutures when annealed to have monofilament sutures are
also referred as Monofilament sutures (Example: Trulene)

 Multifilament sutures as the name indicates has more filaments. The

filaments are twisted and braided to get sutures of required diameter.

 Monofilament sutures are smooth and it is devoid of interstices and

therefore it does not harbour any bacteria on it’s surface. Multifilament
sutures which have interstices which can lead to harbouring bacterias in
the interstices and it can also lead to seepage of body fluid through the
thread as a result of capillary action. To avoid these problems
multifilament sutures are always coated with an inert subsatnce.
Trusilk is coated with Beeswax and Trubond is coated with Silicone.

 Multifilament sutures have the advantages of good handling property,

least memory, good knot security. Monofilament sutures are pliable,
smoother but it needs additional throws while knotting.
 TRULENE (POLYPROPYLENE SUTURES)
 GENERIC NAME: NONABSORBABLE SURGICAL SUTURE, U.S.P.
(MONOFILAMENT POLYPROPYLENE)

TRULENE is a nonabsorbable, sterile, surgical suture, composed of

Polypropylene, a synthetic linear Polyolefin. The molecular formula is
(C3 H6)n.

Trulene is colored blue with Phthalocyanine Copper blue, Color Index No.74160,
an U.S.F.D.A. approved dye. It may be colored with Pigment Blue also.

Trulene is monofilament and it is uncoated.

 U.S.P. SIZES: 1, 0, 2-0, 3-0, 4-0, 5-0, 6-0, 7-0 AND 8-0

 NUMBER OF CODES: 45 Codes for general surgery and 58 codes for

neurological procedures, like Cardio vascular surgery ,
ophthalmic
surgery etc.

 TRULENE WITH NEEDLE: Code numbers begin with the number 8, followed by
two more digits, prefixed by “SN”. If the code number is 3 digits and the first
digit is 8, then it is a general suture and if it has four digits with 8 as the first
digit, it is a Polypropylene suture for use in neurological tissues, like Cardio
vascular, Ophthalmic and Neuro surgeries.
 Important Features of Trulene

 Trulene is a monofilament and is chemically extruded from a purified

and dyed Polymer, Polypropylene.
 It has high tensile strength which it retains indefinitely on
implantation.
 It has extremely low tissue reactivity.
 It can extend upto 30% before breaking and therefore it is useful in
situations where the suture is expected to accommodate post
operative swelling.
 Knotting is secure since the material deforms while knotting and
allows the knot to sit tightly.
 It is smooth and it has low coefficient of friction and therefore slides
through tissue readily.
 It is inert and non biodegradable.
 It is less thrombogenic when compared to Silk sutures
 Rough handling of the suture may cause a fracture on the strand
which may break later in the post operative period causing problems.
 Action and Indications for use (TRULENE)

 TRULENE is indicated for use in soft tissue approximation and or

ligation, including use in plastic and ophthalmic procedures,
cardiovascular and neurological tissues.

 TRULENE being a monofilament suture is remarkably smooth and easy

to handle. Trulene does not have interstices in it's structure.

 It elicits an initial inflammatory reaction in tissues which is followed by

gradual encapsulation of the suture by fibrous connective tissue.

 Trulene is neither absorbed, nor it is subjected to degradation or

weakening by the action of tissue enzymes. Due to its relative biological
inertness, it is recommended for use where the least possible suture
reaction is desired.

 Because of it's lack of adherence to tissues, Trulene is effective as a

pull out suture.

 Trulene, being a monofilament has been successfully employed in

surgical wounds which could subsequently become infected or
contaminated where it can minimize later sinus formation and suture
extrusion.
 TRULON (POLYAMIDE / NYLON SUTURES)
 GENERIC NAME: NONABSORBABLE SURGICAL SUTURE, U.S.P.
(MONOFILAMENT POLYAMIDE OR NYLON)

 TRULON is a nonabsorbable, sterile, surgical suture, composed of long

chain-aliphatic Polymers, Nylon 6 and Nylon 6.6.

 Nylon 6 is formed by polymerisation of epsilon caprolactum.

Nylon 6.6 is formed by Polycondensation of hexamethylene diamine and
adipic acid. The monofilament Polyamide sutures are available in black
and blue colors dyed with FDA approved dyes.

 Blue Nylon sutures is dyed with a blue pigment, colour Index No.69800
Black Nylon suture is dyed with Haematin HCK, (Haematoxylin) color
Index No. 75290.

 U.S.P. SIZES: 2, 1, 0, 2-0, 3-0, 4-0, 5-0, 6-0

 TRULON IS DISPENSED ATTACHED WITH NEEDLE OR WITHOUT
NEEDLE

 NUMBER OF CODES: 31
 Code number is a four digit number, beginning with the number 33, for
needled sutures, when the number is a three digit number beginning with
9 and prefixed with “S” it is a standard suture.
 Important features of Trulon
 Trulon is a monofilament suture, chemically extruded generally in
monofilament form.

 Trulon being a monofilament suture is remarkably smooth and Trulon,

being a monofilament does not have interstices in it's structure.

 Tensile strength is lost by 25% approximately by one year. Due to

gradual loss of tensile strength which may occur over prolonged
periods in vivo Trulon suture should not be used where permanent
retention of tensile strength is required as in fixation of intraocular
lenses or synthetic vascular grafts.

 Passage through tissue is easy because of low coefficient of friction.

 Tissue reaction is minimal.

 Being a degradable suture, unlike Trulene, Trulon is not an effective

pull out suture.

 Trulon tends to be stiffer than Trulene

 Trulon has memory and hence knot security is lower. Additional

throws are needed to have knot security.
 Actions and Indications for use (TRULON)

 Actions:
 Trulon suture elicits a minimal acute inflammatory reaction in tissue
which is followed by gradual encapsulation of suture by fibrous
connective tissue.
 While it is not absorbed, progressive hydrolysis of Nylon in vivo may
result in gradual loss of tensile strength over a period of time.

 Indications for use:

 Trulon is indicated for use in soft tissue approximation and or ligation,
including use in plastic and ophthalmic procedures including use in
cardiovascular and neurological tissues.
 TRUSILK (BLACK BRAIDED SILK)

 GENERIC NAME: NONABSORBABLE SURGICAL SUTURE, U.S.P.

(BLACK BRAIDED SILK)

 TRUSILK is a nonabsorbable, sterile, surgical suture, composed of an organic

protein, called fibroin. This protein is derived from the domesticated species
Bombyx mori (B mori) of the family Bombycidae.

 Natural Silk, which is derived from the cocoon of the Silk worm larvae. It is
basically a protein like Keratin of hair and is covered by an albuminous layer,
a gum like substance. 30% of this extraneous material or gum is removed by
specially developed "Degumming" process. This process is essential for a
compact braid while ensuring that the filaments retain their natural body and
elasticity.

 U.S.P. SIZES: 2, 1, 0, 2-0, 3-0, 4-0, 5-0 and 6-0

 TRUSILK IS AVAILABLE ATTACHED WITH NEEDLE OR WITHOUT NEEDLE

 NUMBER OF CODES: 31

 Code number for needled suture is a four digit number, beginning with the
number 5, prefixed by “SN” and code numbers begin with the number 2,
followed by two more digits, prefixed by “S” for Standard sutures
 Important features of Trusilk

 Silk suture is a braided structure, braided round a core and coated

with wax to reduce capillary action.

 Silk has high tensile strength which is probably totally lost after two
years.

 Silk being a foreign protein, tissue reaction is greater than the other
nonabsorbable sutures.

 The cellular reation is usually Polymorphonuclear and less in intensity

than Catgut sutures.

 Encapsulation of the silk with a fibrous growth usually occurs in 14-21

days.

 Handling property is the best among the nonabsorbable sutures and it

knots easily and securely.
 Actions and Indications for use (TRUSILK)

 Actions:
 TRUSILK elicits an initial inflammatory reaction in tissues which is
followed by gradual encapsulation of the suture by fibrous connective
tissue. While Trusilk is not absorbed, progressive degradation of the
proteinous silk fibres in vivo may result in gradual loss of the sutures
over a period of time.

 Indications for use:

 TRUSILK is indicated for use in soft tissue approximation and or
ligation, including use in plastic and ophthalmic procedures,
cardiovascular and neurological tissues.
 TRUBOND (COATED POLYESTER)

 GENERIC NAME: NONABSORBABLE SURGICAL SUTURE, U.S.P.

(COATED POLYESTER)

TRUBOND is a nonabsorbable, sterile, surgical suture, composed of fine

filaments of Polyester, Poly Ethylene Tere Phthalate. The fine polyester
fibres are braided to produce firm suture that remains soft and pliable.

Trubond is colored green with D&C Green No.5, an U.S.F.D.A. approved

dye. or dyed black with Logwood Extract, conforming to U.S. Code of
Federal regulations. Trubond is available undyed also.

For added lubrication and smoothness, Trubond is coated with highly

biologically inert Silicone.

 U.S.P. SIZES: 2, 1, 0, 2-0, 3-0, 4-0, 5-0 and 6-0

 TRUBOND IS AVAILABLE ATTACHED WITH NEEDLE ONLY.

 NUMBER OF CODES: 27 Codes for general surgery. The code number is

a three digit number, starting with 6 for general surgery sutures and the
number is a four digit number, starting with 6 for sutures meant for
Neurological procedures, Ophthalmic procedures and Cardio vascular
procedures.
 Important features of Trubond

 Trubond is a multifilament, braided suture, composed of Polyester,

chemically extruded from a Polymer known as Polyester, Poly
Ethylene Tere Phthalate.

 Trubond is the suture of choice as a permanent stay suture for the

reasons:
(i) Tensile strength is extremely high and stable forever.

(ii) Trubond is relatively with low tissue reactivity.

 Tensile strength tends to be retained indefinitely and hence it is the

suture of choice for neurological procedures, where the suture is left
permanently.

 Polyester suture is coated with Silicone. Silicone coating is more

preferred than the other coating materials because the diameter is
much consistent.
 Actions and Indications for use (TRUBOND)

 Actions:
 TRUBOND being a braided suture, enables for secured knots.
 Trubond is soft and pliable. It is very easy to handle. It elicits an initial
inflammatory reaction in tissues which is followed by gradual
encapsulation of the suture by fibrous connective tissue.

 Trubond is not absorbed, nor it is subjected to degradation or weakening

by the action of tissue enzymes. Due to it's total biological inertness, it is
recommended for use where the least possible suture reaction is desired.

 Because of it's lack of adherence to tissue, Trubond is effective as a pull

out suture.

 Indications for use:

 TRUBOND is indicated for use in soft tissue approximation and or
ligation, including use in plastic and ophthalmic procedures,
cardiovascular and neurological tissues.
 TRUBOND PLUS SUTURES

 Polyester sutures, meant for Cardio vascular procedures and

neurogical procedures when packed in bulk as Five strands of
Green and Five strands of white, the product is named as
Trubond Plus. Trubond Plus sutures may be attached with
Pledgets as well.

 No.of codes: Nine codes of which four codes are supplied with
Pledgets and the other four without pledgets.

 Pledgets are supplied in dimensions of 3 mm X 3 mm X 1.5 mm

or 6 mm X 3 mm X 1.5 mm
 TRUSTEEL (STAINLESS STEEL SUTURES)

 Trusteel Stainless Steel Surgical Suture is a non absorbable sterile

surgical suture, composed of 316 LVM grade Stainless Steel.

 Trusteel – Monofilament Stainless Steel Surgical Sutures complies

with the requirements of the European Pharmacopeia for
Monofilament Stainless Steel Surgical Sutures and United States
Pharmacopeia for Non absorbable sutures.

 Trusteel Stainless Steel Surgical Suture is available in U.S.P. sizes 1

through 7 (metric sizes 0.7 through 9).

 Number of Codes: 29 Code number is identified with a three digit

number beginning with 6 with prefix TS and the suffix P followed by a
number to indicate the number of sutures per pouch.

 The suture is supplied sterile affixed to various needle types, packed

in dozen per box.
 Important features of Trusteel

 Trusteel sutures has an enviable reputation among the Nonabsorbable

sutures for it’s high strength and total inertness.

 Steel can pull or tear out of tissue and necrosis may result.

 Barbs on the end of the steel can tear gloves, breaking sterile
technique or traumatising the surrounding tissue.

 Kinks in the wire can render it practically useless.

 Trusteel sutures are used in Sternum closure procedures.

 Trusteel suture doesn’t necessitate penetration of the bone and

therefore it prevents bone breaking.

 Trusteel sutures are highly stable, simple to remove and promote

faster healing.
 Trusteel

 Indications for use:

 Trusteel Stainless Steel Surgical Suture is indicated for use in
abdominal wound closure, orthopedic procedures including cerciage
and tendon repair, hernia repair and sternum closure.

 Action:
 Trusteel Stainless Steel Surgical Suture elicits minimal inflammatory
reaction in tissues and is not absorbed.

 Contra Indications:
 The use of the suture is contra indicated in patients with known
sensitivities or allergies to Stainless Steel and it’s constituents,
Chromium, Nickel etc.
CERTIFICATION DETAILS OF NONABSORBABLE SUTURES

Product WHO GMP C.E USFDA

Trusilk Yes Yes Yes

Trulon Yes Yes Yes

Trulene Yes Yes Yes

Trubond Yes Yes Yes

Trusteel No No No
 Summary of technical details about Synthetic absorbable
sutures
 Product Constituent Structure Color Dye Coating

 Trusilk Natural Silk Multifilament Black Log wood Dye * Wax

 Trubond Polyester Multifilament Green D&C Green Silicone

Black Log wood Dye * Uncoated

White Undyed Silicone

 Trulon Polyamide Monofilament Black Log wood dye * Uncoated

Blue Pigment blue Uncoated

 Trulene Polypropylene Monofilament Blue Phthalo cyanine Uncoated

 Trusteel Stainless Steel Monofilament N.A. Not applicable Uncoated

 * Logwood Dye can also be called Haematoxylin or Haematin HCK

Registration documents for products

 1. Product Specifications
 2. Specimen labels and cartons
 3. Product insert
 4. Raw Materials / Packing Materials details
 5. Manufacturing process in brief
 6. Flow chart
 7. In Process quality control checks
 8. Storage and Supply details
 9. Specimen analytical report
 10. Sterilization certificate
 11. Quality Guarantee Certificate
 12. Method of sterilization
 13. Sterilization validation report
 14. Stability study report
 15. Bio compatibility test reports
 Registration documents for products

 16. In vitro cyto toxicity study reports

 17. Test report on Residues of E.O. Sterilization
 18. In vivo implantation study (Retention of tensile strength)
 19. Needle specifications and test methods
 20. Product permission letter
 21. Free sale certificate
 22. C.O.P.P. certificate (WHO GMP)
 23. C.E. Certificate
 24. Design examination certificate
(applicable for Class III devices)
 25. Declaration of Conformity
 26. Risk analysis report
 27. Essential requirements check list
 28. USFDA approval (510 k) letter
 29. Clinical literatures
 30. Product Catalogue
USFDA APPROVAL (510k APPROVAL)

 Product 510 (k) number

 Trulon K 041510
 Trulene K 041511
 Trubond K 041512
 Trusilk K 041514
NONABSORBABLE SURGICAL SUTURES

 THANKS FOR ATTENDING

STUDY SESSION ON
NONABSORBABLE
SURGICAL SUTURES