Frequently Asked Questions

Absorbable Sutures: Resorb in living tissue via enzymatic digestion (natural collagen/catgut) or hydrolysis (synthetic polymers such as PGA, PGLA, PDS, PGCL). They are selected for internal soft tissue approximation where temporary tensile support is needed.

Non-Absorbable Sutures: Resisting enzymatic degradation and hydrolysis, these materials (Polypropylene, Nylon/Polyamide, Polyester, UHMWPE, Stainless Steel Wire) remain permanently encapsulated within tissue or require post-healing removal. They are chosen for cardiovascular, hernia repair, tendon reattachment, and superficial skin closure.

Each material exhibits distinct tensile retention and mass absorption schedules tailored to specific surgical procedures:

• Plain Catgut (UNIGUT): 7 to 10 days tensile retention; mass absorption complete in 60–70 days.
• Chromic Catgut (UNIGUT Chromic): 18 to 21 days tensile retention; mass absorption complete in 90 days.
• PGCL / Poliglecaprone 25 (UNIGLYDE MONO): 50% tensile retention at 7 days; complete mass absorption in 90–120 days.
• PGA / Polyglycolic Acid (UNIGLYDE): 75% tensile retention at 14 days; complete mass absorption in 60–90 days.
• Polyglactin 910 (UNISYNTH): 75% tensile strength retention at 14 days, 50% at 21 days; complete mass absorption within 56–70 days.
• PDS / Polydioxanone (UNISYNTH PDS): Monofilament providing extended wound support up to 6 weeks; complete mass absorption in 180–210 days.

For superficial skin closure and plastic surgery, surgeons commonly select non-absorbable Monofilament Polyamide (UNILON Nylon) or soft absorbable Monofilament Poliglecaprone 25 (UNIGLYDE MONO). Monofilament structures present a smooth surface that eliminates cross-hatch suture marks and prevents bacterial wick action.

Laparoscopic closure relies on handling flexibility, reliable knotting through trocars, and strong burst pressure hold:

• Monofilament Polypropylene (USP 2-0, 3-0) for hernia repair and fascia adaptation.
• Monofilament Polydioxanone (USP 3-0, 4-0) for long-term internal hold.
• Braided & Coated Polyglactin 910 (USP 1) for robust port-site fascia closure.
• Pre-tied Endo Loop Sutures (Catgut or Polyglactin) for rapid vessel and appendiceal stump ligation.

Needle performance depends on raw material selection and heat treatment precision:

Atraumatic Needle: An eyeless surgical needle featuring a precision laser-drilled end into which the suture thread is inserted and permanently crimped (swaged). The needle outer diameter matches the suture thread thickness, creating a smooth transition that minimizes tissue trauma during penetration.

Eyed Needle (Traumatic): Requires threading through a traditional needle eye, resulting in a doubled strand thickness at the pull-through site that increases tissue tear and inflammation.

Precision needle geometry selection covers all surgical disciplines:

• Curvature Profiles: Straight, 1/4 Circle, 3/8 Circle, 1/2 Circle, and 5/8 Circle.
• Point Profiles: Taper Point (Round Body), Cutting Edge, Reverse Cutting, Tapercut, Trocar Point, Blunt Point, and Spatulated Micro-point.
• Needle Sizes: Lengths ranging from 6 mm micro-needles up to 90 mm abdominal wall needles, with optional black finish or ultra-smooth silicone coating.

Surgical needles should be clamped in the needle holder at approximately 2/3 of the distance from the point to the swaged end (a 70:30 ratio). Clamping on or near the swaged attachment can crush the crimp junction and cause suture pull-out, while gripping too close to the point risks tip dulling.

Universal Sutures (Unisur Lifecare Pvt. Ltd.) maintains an ISO 13485:2016 audited Quality Management System. We are notably the second Indian surgical suture manufacturer to achieve EU MDR (Regulation 2017/745) CE Certification across 13 comprehensive product families covering sutures, polypropylene mesh, bone wax, and absorbable haemostats.

Every production batch is tested in our quality control laboratory to ensure tensile strength and needle-attachment pull out force exceed at least 1.1 times (110%) the minimum pharmacopoeial standards required by USP and EP. This built-in safety factor protects knot security during high-tension anatomical closures.

Yes. Our OEM contract manufacturing division provides complete end-to-end solutions for healthcare distributors and brand owners worldwide:

• Custom primary foil packaging and artwork design with multi-language labelling.
• Custom needle-suture code development across 5,000+ active configurations.
• Regulatory dossier supply (STED/CTD format) for local market medical device registration.
• Own Brand Labelling (OBL) technical documentation support under CE and EU MDR frameworks.

For global export and OEM orders, the standard MOQ is 100 dozen cartons per product code. Standard manufacturing lead time is 30 to 45 working days post order confirmation and artwork approval. Expedited dispatch is available for standard fast-moving stock codes.

Sutures are hermetically sealed inside primary aluminum foil packs within ISO Class 7 cleanrooms and terminally sterilized using validated Ethylene Oxide (EO) cycles. Batch release includes mandatory physical tensile testing, needle-pull verification, sterility testing, and bacterial endotoxin (LAL) testing with full CoA documentation.

Surgical sutures must be stored in their original protective cartons in a clean, dry room away from direct sunlight and moisture. Storage temperature must remain controlled below 30°C (86°F) to preserve polymer molecular integrity and primary barrier packaging seals.

Under European Medical Device Regulation (EU MDR 2017/745), animal-derived tissues (bovine/ovine submucosa) face stringent TSE/BSE risk management rules. Synthetic absorbable materials (PGA, PGLA, PDS, PGCL) are preferred for CE markets. However, our Catgut suture lines undergo rigorous viral inactivation and batch testing, making them widely registered across Latin America, Asia-Pacific, the Middle East, and Africa.

We manufacture monofilament polypropylene mesh in non-absorbable and composite structures, offering standard weight, light weight, and macro-porous constructions in sheets (from 6x11 cm to 30x30 cm), pre-shaped keyhole/plug designs, and continuous non-sterile rolls up to 32 cm width for conversion.

HAEMOWAX is a sterile, non-absorbable formulation composed of purified beeswax, paraffin, and isopropyl palmitate. It achieves immediate mechanical haemostasis in bleeding bone channels during thoracic (sternotomy), orthopaedic, neurosurgical, and maxillofacial procedures.

UNISTAT is an absorbable warp-knitted plant-derived haemostatic fabric. Applied directly to capillary, venous, or arteriole oozing sites, it forms a dark gelatinous mass that accelerates clot formation while demonstrating intrinsic in-vitro antimicrobial activity.