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Page 1: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization
Page 2: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

Precision Turning Operations

Precision Turning MachinePrecision Grinding Operations Precision Electrical Spark Erosion Machine

Design Engineering

GEORGE PHILIPS

CORE AREAS OF FOCUS

Established in 1995 by a group of Doctors to provide ‘High Quality Medical Devices’ & incorporating the latest in Engineering & Manufacturing

Technologies, we manufacture & market a wide range of specialized Medical Devices & Disposables, exporting to more than 30 countries worldwide.

We are now a preferred partner to many prestigious international clients for their specific OEM needs.

Our passion & dedication for providing excellent products results in comprehensive and cost effective solutions offering quality & innovative product

designs.

Offering quality products at the right price is the hallmark of George Philips.

Our manufacturing facility uses state of the art engineering & production technologies in an ultra modern factory covering over 30, 000 square feet of

clean room manufacturing floor space (Class 1,000; Class 10,000 & Class 1,00,000)

We strive to maintain the highest standards in design, manufacture, quality control and customer satisfaction by having complete in-house

production capabilities encompassing all major parts of medical device manufacturing.

Develop Core Competencies in Manufacturing

Design & Develop Innovative & New Products

Ensure Consistency in Quality

Lean Manufacturing for Competitive Customer Prices

MANUFACTURING ACTIVITIES

Our complete inhouse & full fledged ultra modern facility enables us to offer our customers the very best in Design Engineering, Rapid Prototyping, Mold

Manufacturing, Clean Room Manufacturing (Injection Molding, Assembly, Printing & Packaging), Process Design-Implementation-Validation, & Sterilization.

DESIGN & DEVELOPMENT

Skilled and experienced Engineers utilize their expertise to design the products

through advanced 3D software programs.

MOLD MANUFACTURING

Our Toolroom, comprises of a fully equipped tool room with the latest

CNC Turning, CNC Milling, CNC Spark Erosion, CNC Grinders, etc.

Using these high precision machines, our qualified & skilled engineers are

able to develop & manufacture in-house high precision molds, jigs, fixtures &

special purpose machines for product manufacturing, processing & assembling.

INNOVATION & PRODUCT DEVELOPMENT

To keep pace with the ever changing needs of the global medical industry we have a full-time R & D team to design & develop new products, using latest

CAD-CAM technology & ensuring fast project completions.

Precision Grinding Machine

Precision Milling Operations

Precision Milling MachinePrecision Electrical Spark Erosion

2

Page 3: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

Clean Room Molding

Clean Room Assembly Operations

ETO Gas Sterilization

High Precision Metrology Measuring & Verification Instruments

Pneumatic Leak Testing

METROLOGY (INSTRUMENTATION)

State of the art

measuring instruments

and equipments are used

to ensure consistency

in product quality.

STERILIZATION

Products are sterilized as per ISO 11135

standards, in Fully Automated EO Gas

Sterilizers.

CLEAN ROOM ASSEMBLY & PACKAGING

All products are assembled in

Class 1,000 & Class 10,000

'Clean Rooms', using special

purpose assembly machines

& each product is tested to

ensure that it meets the

required set standards.

Products are packed

on Automatic Blister

Packaging machine with

facilities for online printing

& coding.

INJECTION MOLDING

We do Clean Room Injection Molding using the

latest high speed injection molding machines

capable of delivering small precise plastic

components in medical & engineering grade

polymers.

MANUFACTURING SERVICES

Contract Manufacturing to major Healthcare companies.

As a ‘Contract Manufacturer’, you will find us to be the right partner,

to manufacture your medical devices & components, right from design

conceptualization to mold manufacturing to molding, clean room

assemblies, packaging & sterilization.

Our Ultra Modern Facility & Latest Manufacturing Technologies ensures

that the end product meets & surpasses your standards in product quality,

sterility & function.

Products can be offered both Packed Sterile & Bulk Unsterile.

QUALITY ASSURANCE & QUALITY CONTROL

Routine in-process quality tests are conducted to ensure that the necessary standards as per the International Guidelines are met. These tests are carried out

through all the different stages of the manufacturing processes, including process validations, until the final product is packed, sterilized & validated for sterility.

Our Quality System, Quality Procedures & Quality Plan ensures that the manufacturing processes & procedures followed, strictly adhere to the predefined

quality control plans & guidelines.

CERTIFICATIONS

All our products are designed and manufactured to meet the requirements of relevant ISO and EN standards. We have been accredited with the following

Quality Certifications: CE, ISO 13485, ISO 9001, WHO GMP, USFDA (Facility Registration), ISO 14001, OSHAS 18001 for our Products,

Quality Systems, Manufacturing Facility, and Environmental & Occupational Safety.

3

Page 4: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

INFUSION THERAPY, I SNTERVENTIONAL YSTEMS

3 SWAY TOPCOCK

360° rotation, with Rotating Male Luer and two Female Luer connectors

For pressure up to 4.5 bar (65 psi)

Minimum priming volume required for accurate drug administration

Arrows indicate direction of flow

Available in White, Red & Blue colors

Options of Low pressure & Lipid Resistant Stopcock

I. V. F RLOW EGULATOR

S P LYRINGE UMP INES

L

With "Y" injection port for, intermittent medication

atex free & with IV set

Constant Flow Rate with a constant Flow range of 5ml to 250 ml/hr

Standard tube length of 40 cm with "Y" site

Kink resistant PVC tubing

GP/IT/3WS/9XXXX

GP/IT/IVF/9XXXX

GP/IT/SPL/9XXXX

H P SIGH RESSURE TOPCOCK

3 Way Stopcock with High Pressure Resistance

For withstanding pressure upto 80 bar (1200 psi)

Available with Rotating Luer Lock

GP/CR/HPS/9XXXX

L P E LOW RESSURE XTENSION INES

K

L

Extension line with options of either 3 WSC & MLL or

MLL & FLL adaptor ends

Extension line suitable for Low Pressure Applications (60 psi )

ink resistant PVC tubing provides smooth fluid movement

engths : 10, 25, 50, 80, 100, 150 & 200 cm

GP/IT/LPL/9XXXX

Ideal for 'syringe pump' infusion therapy & 'infusion therapy' of sensitive

and reactive drugs like Dopamine / NTG / Propofol, etc

Tube ID/OD of 0.90/2.00 mm for Minimal Priming Volume

Fully threaded MLL & FLL at both ends ensure a safe & secure connection

with the syringe pumps

Pressure Stability 5 Bar Hydrostatic

4

Page 5: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

I SNTERVENTIONAL YSTEMS

GP/CR/MNF/9XXXX

GP/HM/PML/9XXXX

GP/CR/HPL/9XXXX

GP/CR/HSY/9XXXX

GP/CR/CSY/9XXXX

S MTOPCOCK ANIFOLD

2 , 3 , 4 Way Large Bore (Lipid Resistant) stopcock manifold with rotating

Male Luer Lock adapter

Color Sequence : White-Blue-Red

Right End Port

All side ports are Female Luer Lock

Flow pattern : 3 way or 4 way

Rigid, crystal clear, non toxic PVC tubing with low priming volume.

Accurate pressure Transmission

Pressure Stability : 5 Bar Hydrostatic

10/25/50/100/150/200 cms

Red/Blue/Yellow/Clear

Other colours, sizes & adaptor options available on request

Lengths :

P M LRESSURE ONITORING INES

Used during various cardiology procedures

10, 12 & 20 ml

Rated Pressure : 500 psi / 1200 psi

Sizes :

Multipurpose extension lines, used for Angiography, Arteriography, etc

Pressure Stability : 500 psi/ 1200 psi

Male Luer Lock at one end and Female Luer Lock at the other

Lengths : 100, 120, 150 cms

Available with Braided & Unbraided tubes

H P E LIGH RESSURE XTENSION INES

C SONTROL YRINGE

H ‘Y’AEMOSTASIS

Provides an easy-to use hemostatic device for both diagnostic &

interventional procedures.

One “Y” valve for all catheter sizes

Large bore

Compatible with catheters from 4Fr upto 9FR

Rated pressure 480 psi without wire

5

Page 6: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

I P MNVASIVE RESSURE ONITORING, DIALYSIS

D D DISPOSABLE IAPHRAGM OMES

D P T KISPOSABLE RESSURE RANSDUCER IT ( DPT )

D P D KISPOSABLE RESSURE OME IT

GP/HM/DDD/9XXXX

GP/HM/DPT/9XXXX

GP/HM/PDK/9XXXX

D C KIALYSIS ATHETER ITS

GP/IC/HDC/9XXXX

CVP MANOMETER

GP/HM/CVP/9XXXX

� Disposable part of transducer, used for monitoring of invasive blood

pressure monitoringSENSEX 1295 (for Hewlett Packard)

SENSEX BNT-TRAN (for Bentley-Trantec)

SENSEX P23 (for Statham P23 ID & XL)

SENSEX MDX (for Medex)

SENSEX 840 (for Capto 840)

SENSEX 844 (for Capto 844)

SENSEX MX960 (for Medex Logical 960)

Consists of Disposable Pressure Transducer, Pressure Monitoring Lines,

Flow-Flush Device, 3 Way Stopcocks, I V Set, Connectors, etc.

Assembled as per customer's specifications

Available as Single & Double DPT Kits

Consists of Disposable Diaphragm Domes, Pressure Monitoring Lines,

Flushing Device, 3way Stopcock, I V Set, etc.

Assembled as per customer's specifications

Available as Single & Double Dome Kits

Continuous or intermittent measurement of Central Venous Pressure

Crystal Clear Rigid Manometer tube, calibrated from (-) 5 to (+) 30 cm

water pressure, connected with a 3 way stopcock & 120 cm extension line

Sliding leveller to record readings for accurate CVP Measurement

Molded clamps with tie bands for secure fixation to the IV stand

Kits contain Dialysis catheter, with marked lengths, color coded clamps,

luer connection hubs, protector caps, etc.

Available as both Straight & Curved catheter types

6

Page 7: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

DIALYSIS , RESPIRATORY & ANAESTHESIA PRODUCTS

AV F NISTULA EEDLE

H B LAEMODIALYSIS LOOD INES

C R R T LONTINUOUS ENAL EPLACEMENT HERAPY INES

GP/HD/AVF/9XXXX

GP/HD/HBL/9XXXX

GP/HD/RRL/9XXXX

V / A CENTILATOR NAESTHESIA IRCUITS

GP/RA/AVC/9XXXX

T PRANSDUCER ROTECTOR

GP/HD/TRP/9XXXX

Siliconised ultra thin walled & sharp bevelled needle to minimize

trauma to the patient

Kink resistant PVC tubing of 30cm length

Flexible wings for proper fixation

Color coded wings for easy size identification (15G, 16G & 17 G)

Blood tubing set consists of arterial and venous lines used during

dialysis, connecting the Dialyzer & Fistula

Chamber designed to reduce foaming & aid in removal of air

Kink resistant blood tubing ensures safe & fast priming

Color coded pinch clamps and dialyzer end connectors

Can be designed as per customer specifications

For Continuous Haemofiltration & slow control of body fluids,

along with the removal of electrolytes, by ultra filtration / diffusion over

an extended period

Used in conditions such as multiorgan failure & acute renal diseases

Design Options available : CAVH, CVVH, CAVHD, CVVHD,

CAVHDF, & CVVHDF

Used as a protective barrier for pressure monitoring during

haemodialysis.

Pressure Stability : 5 Bar Hydrostatic

Sizes: Adult/Paediatric & Neonatal (22mm /15mm/10mm)

Tube types : Corrugated, Extendible, Silicone & Smooth Bore

Available with : Water Traps, HME Filters, Catheter Mounts, etc.

Various customised design options available

22M

22M

22M

22M

Adaptors

Water traps

22F1.5 mtrs.

7.6 mm Port

22M / 15F

H

22F22F

22 mm x 1.5 mtrs.

7

Page 8: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

RESPIRATORY & ANAESTHESIA PRODUCTS

C MATHETER OUNTS

HME / BVF FILTERS

I SNCENTIVE PIROMETERS

GP/RA/RCM/9XXXX

GP/RA/FIL/9XXXX

GP/RA/INS/9XXXX

L M AARYNGEAL ASK IRWAYS

GP/RA/LMA/9XXXX

G AUEDEL IRWAYS

GP/RA/GDA/9XXXX

Latex Free90 Ported & Double Swivel Elbow designs

Standard ISO 15mm & 22 mm fittings

°

Specially designed ported elbow with suction port

15mm Corrugated & Collapsible corrugated tubing

� Adult/Paediatric sizes a

Guards against cross contamination & provides adequate humidification

of the ventilated patient

99.9% filtration efficiency protection against Bacterial/Viral cross infections

Low dead space and low resistance of 2.8 cm H2O at a flow rate of 60 lpm

vailable with Luer Monitoring Port to enable

Proximal Monitoring with safe and secure fittings

Helps

Helps to improve and maintain respiratory fitness post surgical procedures

in maintaining lung capacity of post operative, ambulatory & COPD

patients

Transparent, chambers for accuracy in estimation of exercise capacity

Single ball / 3 ball spirometers available

Facilitates unobstructed oropharyngeal airway passageway during

general anaesthesia

Bite block to prevent biting of tongue and airway occlusion

Color coded for easy identification of sizes (000, 00, 0, 1, 2, 3, 4, & 5)

� Latex Free

An inflatable silicone mask and rubber connecting tube for blind insertion

into the pharynx, forming a low-pressure seal thereby permitting gentle

positive pressure ventilation

The modified surface finish enhances proper adhesion to the oropharygeal

area & reduces the risk of movement & dislocation of the cuff

8

Page 9: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

RESPIRATORY & ANAESTHESIA PRODUCTS, SPINAL PRODUCTS

T TRACHEOSTOMY UBE

S MPINAL ANOMETER

S NPINAL EEDLES

GP/RA/TCT/9XXXX

GP/RA/SMS/9XXXX

GP/RA/SPN/9XXXX

O MXYGEN ASKS

GP/OA/OXM/9XXXX

E KPIDURAL ITS

GP/RA/EDK/9XXXX

Made from non-toxic, clear, kink-resistant PVC material to protect delicate

mucosal tissue. Rounded and smooth tip of the obturator minimizes tissue

drag during intubation

15mm connector can be rotated in 360 degree direction to facilitate a safe

connection to the breathing system

Plain / Cuffed types available in different sizes

For accurate measurement of CSF (Cerebro Spinal Fluid) pressure

Fine bore clear manometer tube

Tube ID 0.9 mm & Priming Volume 0.5 ml

Rigid calibrated scale from '0 to 50' cms

Used during Spinal Anaesthesia

High flow rate enables faster Cerebro Spinal Fluid flashback

Transparent polycarbonate hub offers easy visualization of CSF or blood

Bevelled tip for smoother penetration.

Needle sizes : 16 G to 30 G x 3.5 cms

Kit contains Epidural Catheter, with a flexible and atraumatic soft tip

Tuohy needle with clear depth markings for accuracy of readings

Threading Assist guide

Loss Of Resistance (LOR) syringe

Suitable for oxygen therapy & designed for patient comfort

Soft Vinyl Mask, Latex Free, Easy fit, Soft Elastic Strap

Kink Resistant Tubing of 1.8 mts, facilitating unobstructive oxygen flow

& Adjustable Nose Clip

Available in Adult and Paediatric sizes with and without tubing

9

Page 10: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

OXYGEN & AEROSOL THERAPY, CARDIOVASCULAR SURGERY, CATHETERS

N C & N CASAL ANNULA ASAL ATHETER

N MEBULISING ASK

C D / T CHEST RAINAGE ROCAR ATHETER

GP/OA/NAC/9XXXX

GP/OA/NBM/9XXXX

GP/CT/TDC/9XXXX

CVC (C V C ) KENTRAL ENOUS ATHETER ITS

GP/IC/CVC/9XXXX

C PUSTOM ACKS

GP/CT/ECC/9XXXX

Suitable for direct delivery of oxygen through the naso-pharynx

Kink resistant, soft nasal prongs. Adjustable fitting, latex free

Available in different lengths and can be customized to match a wide range

of respiratory equipment

Sizes : Adult / Pediatric / Neonatal

Used for patients requiring nebulisation therapy (Asthma & COPD)

Adult & Paediatric sizes available in different combinations of nebulising

chamber, mask, mouth piece & tubings

Extra Corporal Circuit Packs for use with heart lung machines

Consists of complete set of tubes, connectors and accessories

Available with options of various designs & sizes for 'Straight', 'Reducer' &

' Y-Connectors', with or without 'Luer’

Packs available as standard and custom designs

To catheterize central venous using ‘Seldinger’ Technique

Kit includes Catheter, Dilator, Guidewire, Syringe, Introducer Needle,

Scalpel & Tube Fixators. Catheter made from soft, pliable, radiopaque &

thermosensitive polyurethane. Smooth surface minimizes platelet

aggregation & subsequent thrombosis.

Available in Single/Double/Triple Lumen Catheter kits (Adult & Paed)

For post operative & quick non operative pleural and chest drainage (with

trocar) in conditions such as tension pneumothorax

Embedded radiopaque stripe with depth markings at 2 cms enables accurate

catheter positioning. Multiple rounds tipped, atraumatic, cross side eyelets,

offer large entry areas for drainage

Sizes : 16 F, 20 F, 24 F, 28 F, 32 F, 36 F

10

Page 11: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

 

Medical Device Contract Manufacturing Services OF GPME

OEM & Contract Manufacturing Services Offered  1. Engineering Design Services ( Product Design & Mold Design ) 2. Mold Manufacturing 3. Injection Molding ( In class 10,000 & class 1,00,000 molding rooms ) 4. Assembly ( In class 1,000 & class 10,000 clean rooms ) 5. Printing ( Pad Printing ) 6. Ultrasonic Welding 7. Packaging ( Automatic Blister Packing, Thermoforming ( Forming, Sealing, Cutting ) ) 8. ETO Gas Sterilization 

 

Address  Office : M/s. GEORGE PHILIPS MEDICAL ENGINEERING Pvt. Ltd. 304, 3rd Floor, Gemstar Commercial Complex, Ramchandra Lane Extn., Kanchpada, Malad Link Rd., Malad (West), Mumbai 400064, Maharashtra, INDIA; Tel : 00‐91‐(0)‐22‐28442884 ; Fax : 00‐91‐(0)‐22‐28442885  

Factory : M/s. GEORGE PHILIPS MEDICAL ENGINEERING Pvt. Ltd. ( An 100 % EXPORT ORIENTED UNIT ) B ‐ 43, MIDC, Anand Nagar, Additional Ambernath, Ambernath ( East ), Thane District, Pin 421506, Maharashtra, INDIA; Email : [email protected] ; Website : www.georgephilips.com 

 

Certifications   ISO 9001  ISO 13485  ISO 14001  OHSAS 18001  CE ( Medical Device Directive 93/42/EEC )  WHO GMP  Indian FDA ( Drug Manufacturing License )  US FDA ( Facility Registration ) 

 

Engineering Depts.   

Design & Development  Depts. Area  Machines & SystemsDesign & Development  600  Latest CAD‐CAM systems & programmesTool Room  2,500  CNC Milling, CNC Lathe, CNC EDM, Surface Grinder, Radial Drills, Micro WeldingInstrumentation  150  Profile Projector, Tool makers microscope, Video Measuring Machine

 

Validated Clean Room Spaces   

Department  Classification Injection Molding  Class 1,00,000Assembly  Class    10,000Sterilization  Class 1,00,000Blister Packing & Printing  Class    10,000Microbiology & Sterility Testing Class    10,000

 

International Standards being followed in George Philips Manufacturing Activities  

Company Indian FDA (Drug Manufacturing License) Mfg. Lic.: KD 505

US FDA Facility Establishment Registration Regn. #: 3008044441

Quality Systems 

Medical Devices Regulations  ISO 13485 : 2003

Quality Management Systems  ISO 9001 : 2008

Good Manufacturing Practice  FDA Schedule M III

Environmental Management Systems ISO 14001 : 2004

Occupational Safety Management Systems OHSAS 18001 : 2007

Products  European Medical Device Regulations CE under MDD/93/42/EEC 

Processes 

Sterilization  ISO 11135 : 2007 & ISO 11138 : 2006 

Risk Management For Medical Devices ISO 14971 : 2009

Biological Evaluation Of Medical Devices ISO 10993 : 2009

Labeling & Packing  EN 980 : 2008 

Page 12: GEORGE PHILIPSgeorgephilips.com/GPME_PDF.pdfOffering quality products at the right price is the hallmark of George Philips. ... Process Design-Implementation-Validation, & Sterilization

Email : [email protected]@vsnl.net

Web : www.georgephilips.comSkype: georgephilipsmedical

Email :