specialized sterile formulations for …«specialized sterile formulations for strategic alliance «...

«  SPECIALIZED STERILE FORMULATIONS FOR STRATEGIC

ALLIANCE

«  GLOBAL FACILITY FOR STERILE FORMULATIONS

911, G.I.D.C., Makarpura, Vadodara-390 010, Gujarat, India.Phone / Fax : 91-265-2638063, 2636630Email : info@astralsteritech.comWeb : www.astralsteritech.com

"It is not the strongest of the species that survive, nor the most intelligent but the one most Responsive To Change & Challenges.’’

Dr. Dushyant PatelChairman & Managing DirectorM. Pharm, Ph. D. FIC, C. Chem, MRSC.

LOCATION

SITE LAYOUT

FACILITY PROFILE

Conceptualized and established by Dr. Dushyant Patel in year 1991.

The state of the art manufacturing facilities having dedicated blocks of ß-Lactam.

•  CEPHALOSPORIN range of sterile antibiotic powder products.

•  SEMI SYNTHETIC PENICILLIN range of sterile antibiotic powder products.

BUILDING-2

BUILDING- 1 (SSP Block)

(Cephalosporin Block)

PHILOSOPHY - SEGREGATION & CONTAINMENT

COMPREHENSIVE SEGREGATION OF :

•  Personnel •  Material •  Equipment •  Utilities

CONTAINMENT :

•  Air Sinks •  Air Showers •  Dedicated Laundry •  Dedicated Dinning Area

FACILITY HIGHLIGHTS

•  Clean Rooms - Clestra, France •  Powder Filler – Macofar, Italy •  Online Leak Detection System – Wilcomat, Switzerland •  Rapid Environment Isolates Identification - Vitek 2 Compact – Biomerieux, France

•  FDCA - Gujarat•  WHO - (CDSCO, INDIA) •  CDER – US FDA

•  Health Products and Food Branch Inspectorate (HPFBI) - Health Canada•  Therapeutic Goods Administration (TGA) – Australia (2004-2007)

•  ANVISA – Brazil (2004 – 2008)•  Medicine Control Council (MCC) - South Africa•  Ministry of Health and Family National Medicines Agency – Romania•  Ministry of Public health and Population - Republic of Yemen•  NAFDAC – Nigeria•  NDA – Uganda•  MCAZ – Zimbabwe•  MOH – Ukraine•  MOH – TanzaniaAPPROVED AS GLOBAL MANUFACTURING SITE BY:•  CQA / CRC - Pfizer, U.S.A. CQA - Sandoz, Austria

REGULATORY PROFILE

CUSTOMER PROFILE :

•  Pfizer•  Zoetis•  Sandoz, India•  Lupin •  Cadila (Zydus)•  Micro Labs

Business Alliances :

•  Sagent, USA•  Novartis, Thailand•  Unilab, Philippines•  Natco Pharma•  S. M. Pharmaceuticals, Malaysia•  Citihealth Imports (Pvt) Ltd., Sri Lanka•  Canopus inter-trade Pte Ltd., Vietnam•  Bio–Tech, South Africa

•  Alembic •  Unique (J.B. Chemicals &

Pharma. Ltd.)•  Orchid HealthCare

RECOGNITIONS AWARDS

National Award and Certificate of Excellence Bestowed upon Dr. Dushyant R. Patel by the then Hon'ble President of India Dr. S. D. Sharma - As Outstanding Small Scale Entrepreneur,

Best SSI Unit in Gujarat Award from Federation of Gujarat Industries (FGI)

Exemplary SSI Unit and Good House Keeping Award from Vadodara Chamber of Commerce and Industries (VCCI)

PROFESSIONAL AFFILIATIONS (Dr. Dushyant R. Patel)

Chartered Chemist & Member - The Royal Society of Chemistry, Cambridge, U. K. Since 1991

Chairman - Indian Drug Manufacturer's Association (IDMA) Gujarat State Board. Year-1998-2000

Member - Indian Drug Manufacturer's Association (IDMA) Central Executive Council, Mumbai.

Trustee & Governing Body Member - "Shri B. V. Patel Pharmaceutical Education and Research Development Center"

Member - Advisory Committee & Board of Studies of Pharmacy Department and Faculty of Management, M. S. University, Vadodara

President - Indian Pharmaceutical Association, Vadodara, Year 2000-2004

Winner of IDMA-Quality Excellence Award : Silver Trophy & Gold Award

SOCIAL & COMMUNITY SERVICES : •  Contributions to institutions like Chinmaya Mission, NGOs and professional associations IPA/IDMA towards students' scholarships, support to victims of natural calamities.

•  Supply of free medicines through charitable institutions for needy & poor patients of cancer and life threatening diseases.

Dr. Dushyant R. Patel, receiving National Award for Out Standing Small Scale Entrepreneur from Late Dr. Shankar Dayal Sharma, Hon. President of India. ASTRAL is the first ever recipient of this award for the State of Gujarat.

Celestial Sincerity for Customer SatisfactionASTRAL -

Building - 1 STERILE SEMI SYNTHETIC PENICILLIN

FORMULATIONS FACILITY (SSP)

AIR SHOWER Bldg. 1 (SSP)

STERILE CORRIDOR Bldg. 1 (SSP)

Rubber Stopper Processor and Steam Sterilizer PLC Controlled Sterilization & Drying

UNLOADING AREA Bldg. 1 (SSP)

Steriliza)on&Depyrogena)onTunnel

RotaryVialWasher

Bldg. 1 (SSP)

FILLING MACHINE Bldg. 1 (SSP)

VIAL SEALING Bldg. 1 (SSP)

VIAL INSPECTION Bldg. 1 (SSP)

•  Precision Leak Tester designed to detect leaks using Vacuum Decay Method.

LEAK DETECTION SYSTEM Bldg. 1 (SSP)

CAMERA BASED VISION SYSTEM Bldg. 1 (SSP)

NoLabelVialRejec.onSystem

AUTO CARTONATOR Bldg. 1 (SSP)

DEDUSTING Bldg. 1 (SSP)

DECARTONING OF VIALS Bldg. 1 (SSP)

•  Independent Hot Loop Systems for WFI and Purified water, compliant to USP •  PW and WFI piping of SS 316-L with Orbital welding duly passivated

•  Proper Gradient for complete drain

•  Zero dead leg valves at POU

•  Sanitization with pressurized super saturated hot water

•  PLC based monitoring and control

WATER SYSTEMS Bldg. 1 (SSP)

Critical Areas - Blending & filling - Designed to achieve RH below 25 %

Service floor on the walkable ceiling (Clestra) hence no entry of maintenance personnel in critical areas.

HEPA filters from Camfil FarrEU 14 specification (99.999 % efficiency)

Aseptic Zone AHU-1 Filtration, Drying & Crystallization Area

Aseptic Sterile Zone AHU-2 Blending

Clean Zone AHU-3 Air Lock to RM Day Store, RM Day Store, Wash Tunnel & Air Lock Wash Tunnel

Aseptic Zone AHU-4 Sterile Air Lock, Material Staging, Filling Area

Aseptic Zone AHU-5 PAL-4 & PAL 5

Aseptic Zone AHU-6 PAL-2, PAL-3 & PAL-6

Clean Zone AHU-7 Man Air Lock, General Wash, Material Air Lock, Loading, & Clean Utensil

Clean Zone AHU-8 Capping & Air Lock

HVAC SYSTEM Bldg. 1 (SSP)

Building - 2 STERILE CEPHALOSPORIN POWDER

FORMULATIONS FACILITY

AIR SHOWER Bldg. 2 (Cephalosporin)

MAIN CORRIDOR Bldg. 2 (Cephalosporin)

A view of Clean Area

Bldg. 2 (Cephalosporin)

Vial Washer

Sterilization & Depyrogenation Tunnel

Bldg. 2 (Cephalosporin)

FILLING MACHINE Bldg. 2 (Cephalosporin)

•  Precision Leak Tester designed to detect leaks using Vacuum Decay Method.

LEAK DETECTION SYSTEM Bldg. 2 (Cephalosporin)

CAMERA BASED VISION SYSTEM Bldg. 2 (Cephalosporin)

NoLabelVialRejec.onSystem

AUTO CARTONATOR (Bldg. 2 Cephalosporin)

DEDUSTING Bldg. 2 (Cephalosporin)

DECARTONING OF VIALS Bldg. 2 (Cephalosporin)

•  Independent Hot Loop Systems for WFI and Purified water, compliant to USP

•  PW and WFI piping of SS 316-L with Orbital welding duly passivated

•  Proper Gradient for complete drain

•  Zero dead leg valves at POU

•  Sanitization with pressurized super saturated hot water

•  PLC based monitoring and control

WATER SYSTEMS Bldg. 2 (Cephalosporin)

WFI SYSTEM

PSG

PW SYSTEM

MCDS

Critical Areas - Blending & filling - Designed to achieve RH below 25 %DAS - from Sauter, France & Race Technology.Service floor on the walkable ceiling (Clestra) hence no entry of maintenance personnel in critical areas.

Sterile Zone A AHU-1 Vial Filling & Blending Room

Sterile Zone B AHU-2 Sterile Lobby, Material Staging Room , Air Lock & Cap sealing Room

Sterile Zone C AHU-3 Unloading Area, Material Air lock II, Janitor, Exit Air Lock & Air Lock-1, 2 & 3

Non-Sterile Zone AHU-4 Vial Wash Room, Material air Lock 1, Washing Area Air Lock, Clean Utensil Store & Loading Area

Normal Zone AHU-5 Corridor, Conference Room & offices

Normal Zone AHU-6 Central Packing Area HEPA filters from Farr Europe - UK EU 13 specification (99.99% efficiency)

HVAC SYSTEM

Bldg. 2 Ceph.

WARE HOUSE & STORAGE

PACKING MATERIAL STORE

FINISHED PRODUCT STORE

QUALITY CONTROL

Quality Control Laboratory

Quality Control Laboratory

Quality Control Laboratory

MICROBIOLOGY LABORATORY Bldg. 1

Closed Sterility Apparatus

VITEC-2 Compact(for rapid identification of organisms

up to spices level)

Quality Control Laboratory (Microbiology)

Double Door Sterilizer & Pass Boxes

Quality Control Laboratory (Microbiology)

STABILITY CHAMBERS

Walk-in Stability Chambers

Cephalosporin Group Cefotaxime for Injection 250 mg / 500 mg / 1 g

Cefazolin for Injection 250 mg / 500 mg / 1 g

Ceftriaxone for Injection 250 mg / 500 mg / 1 g / 2 g

Cefuroxime for Injection 250 mg / 500 mg / 750 mg / 1 g / 1.5 g

Ceftazidime for Injection 250 mg / 500 mg /1 g / 2 g

Cefoperazone for Injection 250 mg / 1 g / 2 g

Cefepime for Injection 500 mg / 1000 mg / 2000 mg

Cefpirom for Injection 1000 mg

Ceftiofur for Injection 250 mg / 1000 mg / 4000 mg

Semi Synthetic Penicillin Group

Amoxicillin Sodium for Injection 250 mg / 500 mg / 1g / 2g Ampicillin Sodium for Injection 250 mg / 500 mg /1 g / 2 g

Cloxacillin Sodium for Injection 250 mg / 500 mg /1 g Amoxicillin & Di-Cloxacillin Sodium for Injection 500 mg / 1 g / 2.5 g / 3 g / 4 g

Clavulanate Potassium & Amoxicillin Sodium for Injection 600 mg / 1.2 g Ampicillin & Cloxacillin for Injection 75 mg / 500 mg / 1 g / 2 g / 3 g / 4 g

Ampicillin & Sulbactam for Injection 1.5 g Piperacillin & Tazobactam for Injection 1.125 g / 2.25 g / 3.375 g / 4.5 g

Oxacillin for Injection 1 g / 2 g / 10 g

Nafcillin for Injection 1 g / 2 g / 10 g

PRODUCT RANGE : STERILE POWDER FORMULATIONS

Global Presence of Products Manufactured at Astral

•  Mexico •  Jamaica •  T & T Countries •  Peru •  Brazil •  Venezuela •  Ecuador •  El Salvador •  Guatemala

•  Philippines •  Malaysia •  Vietnam •  Myanmar •  Sri Lanka

•  Kazakhstan •  Russia •  Azerbaijan •  Ukraine •  Latvia

•  Canada

•  South Africa •  Zambia •  Ivory Cost •  Congo •  Albania •  Tanzania •  Uganda •  Zimbabwe •  Nigeria •  Malawi •  Republic of Dominica

•  Yemen

•  Romania •  China

•  USA

Thank You

Celestial Sincerity for Customer SatisfactionASTRAL -