B L Lifesciences BL Lifesciences Medical Device Manufacturing

B L Lifesciences

BL Lifesciences Medical Device Manufacturing Company Established in 1984 Part of the 65 years old BL Group of companies. . Started as family owned business run by the Aggarwal family. . Group activities include one of the largest & oldest Pharmacy in Delhi, Exports of Apparel… besides Manufacturing & Marketing several Bio Medical Devices in India and internationally

BL Lifesciences specializes in the fields of Cardiovascular Surgery Cardiac Anesthesia Critical Care Interventional Cardiology

BL Lifesciences Manufacturing Distribution for several indigenous, own branded products representing several world leaders in the fields of Medical Technology. .

Distribution Products • • • • • Integra Luxtec, USA (Head light source, Camera system) Integra Omni-Tract, USA (Retractors) Scanlan, USA (Surgical Instruments) 3 M - Arizant, USA (Patient warmers, Fluid/Blood warmer) Chase Medical, USA (Cardiovascular shunts) Helena Lab. , USA (ACT machine) Minntech, USA (Hemoconcentrators) Medos, Germany (Oxygenators and others) Vitalitec Corpn. , France (Hemostasis Clips) On-X, USA (Heart valves) Cryolife, USA (Surgical glue) Thoratec, USA (Left Ventricular Assist Device) Novalung, Germany (Membrane ventilator) Rontis, Swiss (Coronary stents) Oscar, USA (Angiography catheters and other) Minvasys (Bifucation stents) Nonin, USA (Cerebral Oxymetry) Purple Surgical (Laproscopy Instruments)

BL Manufacturing

Operations Employing over a total of 400 people in the medical division. . With strong sales force of 70 personnel. . Spread over 11 branches and additional 10 regional / representative offices across India. . • Corporate Office : A 245, Okhla Industrial Area, Phase 1, NEW DELHI, 110020, India • 11 Branch offices INDIA : New Delhi, Chennai, Bangalore, Hyderabad, Mumbai, Calcutta, Lucknow, Ahmedabad, Chandigarh, Jaipur, Pune • 10 Regional Representative Offices INDIA : • 2 Manufacturing Facilities INDIA : Greater Noida (Facility 1 & Facility 2 –under construction/renovation ) • 3 Rep Offices OVERSEAS : Singapore, Dubai UAE, Italy (EU Rep)

BL’s NETWORK All India Presence

BL Manufacturing facility at Greater Noida

Manufacturing facility • Located in Greater Noida , India. About 32 kms outside of the Delhi. • State of Art Building designed in Compliance to all Statutory / Regulatory requirements , our product requirements & future growth in mind • Total built up area • Ware House : 68, 000 sq. ft. : 25, 000 sq. ft.

Manufacturing facility • Current Staff Strength of over 200 operators and 50+ support functional staff • Seasoned design team , skilled production personnel and competent Quality Control Team. • Procurement & Supply Chain management team is experienced & well versed with the dynamics of Business.

Manufacturing facility • Class 10, 000 Clean room for Assembly of products. Clean Room ISO class 7 : 4, 200 sq. ft. • Additional space available to add another Clean room of 4000 sq ft. Space available to add another ISO class 7 clean room of 4, 000 sq. f. S • In house Molding & Tray forming Molding : 3, 000 sq. ft. • In house EO Sterilization Facility – 750 cu ft. • Fully Integrated Microbiological Lab.

Certifications & Compliances • Compliance to Indian FDA • Factory and Premises : The Drugs & Cosmetics Act 1940 & Schedule M-III • ISO 9001 : 2008 /13485: 2003 • CE Mark

Certification ISO

Certification CE

Certification & Compliances • Compliance to all Statutory & Regulatory Requirements • Cleanroom and associated environments : ISO 14644 -1: 2009 • Biological Evaluation of Medical Devices : ISO 10993: 2009 • Symbols to be used in Medical device Labels : ISO 15223 -1: 2007 • Application of Risk Management : EN 14971: 2009 • Sterilization of health Care products : ISO 11135 -1: 2007

Manufacturing Activities at BL

Controlled entry into the production area

ASSEMBLY AREA Class 10, 000

ASSEMBLY LINES

INHOUSE EO STERILIZATION Two Sterilizers 540 & 200 Cu ft Total Sterilization volume per day is 750 packs

Quarantine & Storage Area

BL’ s STRENGTH Expansion Plans of BL In Addition to the Present Assembly Area; space available to add another Clean room of 4000 sq ft Adequate Storage Capacity Available too

BL for Tubing sets

TUBINGS CLASS VI PLAIN /REGULAR DEHP FREE OPTIONS COLORED

STERILIZATION INDICATORS

ASSEMBLY LINES PERFUSION PACKS – TRAY FILLING

ASSEMBLED PACK With EO INDICATOR

Visual Inspection of Sealing

High Quality Products at Competitive Cost

Product is CE certified

BL’ s STRENGTH • BL has been a leading Perfusion pack Manufacturer in INDIA since Year 2000. This is in addition to other product ranges of BL. • BL’s current Annual Production capacity for Perfusion Pack is in excess of 70, 000 packs with a Single Shift Operation. We have the potential to run multiple shifts to increase the Production Capacity.

BL’ s STRENGTH High Level of Customization requires us to stay in regular touch with each and every customer of regular basis

BL’ s STRENGTH • The Designs are created to suit all Users with Options of components for all Adult /Pediatric /Neonatal/Infant applicatio. • Custom drawings can be made as early as 48 hours • Sterile Samples are available at a short notice for Clinical Evaluations

BL’ s STRENGTH • Products are available in short lead times as the Sterilization Process is In - house • Customized Labeling available along with GS 1 Barcoding

So how does BL’s strength lend you Competitive advantage ? Fast Track Processing Quick processing of drawings & price offer Fast sampling Customized label options Flexibility on minimum order quantity

CUSTOMIZATION The design can be customized with a interactive approach between BL & buyer to minimize the cost impact.

Shelf life 3 years, validated

Tubing • Class VI Implant Tested • Biocompatibility as per ISO 10993 • Options of Colored Tubing • Options for DEHP Free Tubing

Labels • GS 1/GTIN barcodes • Custom Labels available

In House Sterilization • Sterile samples available in less time • Production can be Fast Tracked

Sterilization indicators • EO Tape Inside the product • EO Indicator on the Product Header Bag

Tray Packaging All the tubing sets are packed with the TRAY to avoid Product Damage

Dedicated team Years of Manufacturing Experience Trained & experienced Operators/Supervisors Trained & experienced Quality Team

Thank you