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Precision Turning Operations
Precision Turning MachinePrecision Grinding Operations Precision Electrical Spark Erosion Machine
Design Engineering
GEORGE PHILIPS
CORE AREAS OF FOCUS
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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.
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Develop Core Competencies in Manufacturing
Design & Develop Innovative & New Products
Ensure Consistency in Quality
Lean Manufacturing for Competitive Customer Prices
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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
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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.
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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.
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INFUSION THERAPY, I SNTERVENTIONAL YSTEMS
3 SWAY TOPCOCK
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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
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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
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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
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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
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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
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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 :
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P M LRESSURE ONITORING INES
Used during various cardiology procedures
10, 12 & 20 ml
Rated Pressure : 500 psi / 1200 psi
Sizes :
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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
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H P E LIGH RESSURE XTENSION INES
C SONTROL YRINGE
H ‘Y’AEMOSTASIS
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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
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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)
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SENSEX 840 (for Capto 840)
SENSEX 844 (for Capto 844)
SENSEX MX960 (for Medex Logical 960)
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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
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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
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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
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Kits contain Dialysis catheter, with marked lengths, color coded clamps,
luer connection hubs, protector caps, etc.
Available as both Straight & Curved catheter types
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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
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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)
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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
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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
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Used as a protective barrier for pressure monitoring during
haemodialysis.
Pressure Stability : 5 Bar Hydrostatic
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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.
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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
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Latex Free90 Ported & Double Swivel Elbow designs
Standard ISO 15mm & 22 mm fittings
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Specially designed ported elbow with suction port
15mm Corrugated & Collapsible corrugated tubing
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� 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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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Used for patients requiring nebulisation therapy (Asthma & COPD)
Adult & Paediatric sizes available in different combinations of nebulising
chamber, mask, mouth piece & tubings
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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
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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)
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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
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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