Containment Brochure '09

Bectochem

Containment

www.bectochem.com

Consultants & Engineers Pvt. Ltd.

innovative engineering

FROM CHAIRMAN’S DESK

Chairman, Mr. R. M. Bector believes unwavering commitment to Innovation would put companies on a pedestal of growth.

We have a Dream, a dream that one day, Bectochem would be one of the most admired companies in Process Equipment circles, a

dream which can only be achieved through an unwavering commitment to innovation. At Bectochem, we are fostering innovation through manufacturing expansions viz. Tie-Ups, Joint Ventures & Research Investments.

It is easy look over the past three decade with great deal of satisfaction, as Bectochem has flourished into full-blown diversified organization operating in India and in several parts of the globe. But looking back has never been our style. Yes, we have looked back in the past to do an introspection, to check out our strengths and build on them for the long & winding journey that lies ahead.

The volatile market condition is a test for capabilities in these testing times and would in all likelihood ensure the survival of the best. And this very class of companies would emerge fitter and stronger than ever before. It is the right technological solution in the offing along with the flexibility & productivity which would ensure customer delight will only excel and lead the race.

Continuing with the Innovation in the Pharmaceutical and Biotechnology arena and with the advent of the increased potency of active ingredients, there was need for the specialized containment system. With the Introduction of barrier isolator technology in India in 2004, Bectochem is the acknowledged expert in the specialized and technically demanding field of design manufacture of High Specification Barrier Containment System.

Our organization is fuelled by a young, professional and self-motivated team of 250+ Bectochemites and their pioneering and commendable efforts that have put the company on the pedestal of growth. My regards also go to the workforce who have contributed with their might of hard work and drilled those obstacles which obstructed the status-quo of the organization.

We, at , now approach you to develop a mutually beneficial relationship, a relationship that would last for years to come.

Bectochem


R. M. BectorChairman

COMPANY PROFILE

Containment

Headquarters at Mumbai, Maharashtra State: Mumbai is the Commercial capital of India and is well connected through Sea, Air & land. Mumbai is the largest port in the country & has an International airport and a well structured road network. Bectochem headquarters in Mumbai houses the Design & Marketing teams which are responsible for some of the biggest innovations in Indian Pharmaceutical Industry.

Manufacturing facility at Ankleshwar, Gujarat State: Gujarat is well connected with about 74000 km of roads, 11 domestic airports and 1 international airport (at Ahmedabad), and the Indian Railway network. Gujarat industry produces 35% of India’s pharmaceutical products. Established as our main work centre here in 1988, Ankleshwar facility spans 100,000 sq. ft. and is equipped with state of the art equipment.

Manufacturing facility at Pune, Maharashtra State: Pune is among the fastest growing industrial regions of the country. Daimler Chrysler has its assembly line for its Mercedes Benz brand in Pune, a prominent place for major software and business process outsourcing companies and a centre of engineering excellence. The city is known as “Oxford of the East”. The above facts along with the growing need for decentralization of manufacturing led us to establish an additional manufacturing facility in Pune.

Bectochem

Bectochem Consultants & Engineers Pvt. Ltd. boasts of offices & associates dedicated to Sales & Client Servicing worldwide.

ASSOCIATES WORLDWIDE

The offices are in AustraliaBangladesh

China EgyptGermanyIsrael ItalyPakistan Russia

UK USA

In India, the associates are in

Ahmedabad, Bangalore, Hyderabad, Chennai, New Delhi


UAE

Founded in 1978 to manufacture pharmaceutical process equipment.

Bectochem produces a comprehensive range of equipment including rapid mixer granulators, fluid bed driers and processors, mills, blenders, coaters & turnkey solids dosage and liquid manufacturing systems.Introducing barrier isolator technology to India in 2004, Bectochem is the acknowledged expert in the specialised and technically demanding field of design & manufacture of high specification barrier containment systems.

The Industries We ServePharmaceuticalAPI ManufacturingSolids FormulationsLiquid FormulationsOintment FormulationsResearch & DevelopmentFoodCosmetics

Bectochem’s product range is to be found in facilities across 5 continents.We strive to provide continuous improvement in our quality and customer satisfaction, supplying right first time and on time with fast manufacturing lead times.

Bectochem will strive to build mutually beneficial partnerships with engineering enterprises to enable it to be a spearhead in offering turnkey, single window solutions to customers in:

• Pharmaceuticals• APIs• Food & Beverages• Chemicals• Project Consultancy• Validation

In the next 5 years we will strive for excellence in. • Containment Solutions• Elite Pharma Customers• International Market

A number of steps are being taken to achieve this:• Differentiating the Business into smaller entities with self governing control centre’s.• Establishing of beach heads in Europe and USA• Implementation and Auditing of Good Manufacturing Practices to International standards

Vision

“To be an innovative process engineering company catering to a global market with Dynamic, Proactive, Customer driven approach”

Mission

Bectochem

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COMPANY PROFILE

Containment

Containment

The investments made by our company in people and facilities for the past decades have yielded a proud history of innovations in many forms of processing;

Bectochem was the first in the country to successfully integrate the impeller lifting arrangement in High Shear Mixer Granulator (HSMG/RMG). This catapulted us to be theleader in RMG in the country.

We were the first in the country to incorporate the Diverter panel technology into WIP and CIP lines

First to make fully automatic granulation line in the country

First to manufacture Autocoater with a fully automatic wash in place system

We are the only Asian Pharmaceutical Machinery manufacturers to jointly own a fullyfunctional Granulation Lab in Europe.

FOREIGN ASSOCIATIONS


HECHT Anlagenbau is a major supplier of Machinery to Bulk Drug Manufacturers. They are specialists in simplifying the in-house transfer of raw materials in the chemical, pharmaceutical and food industries. HECHT Anlagenbau is focused on contamination-free systems. With the aid of specially developed systems that take the utmost care when filling containers, HECHT Anlagenbau are leaders in the manufacture of filling and discharging machines for FIBC, containers, barrels, sacks and cardboard boxes. They have EN ISO 9001:2000 certified Quality Management System.

HALLMARKS

COMPANY PROFILE

CLIENTELE


Glaxo Smith Kline R&D Facility, Nashik, IndiaSandoz, IndiaDr. Reddy’s Laboratories, India, US FDA Approved Aurobindo Pharma Ltd, India, UK MCA ApprovedDabur India Ltd. Now Fresenius Kabi – US FDA, UK MHRA ApprovedNatco Pharma Limited, IndiaJB Chemicals, India, MCC ApprovedElder Pharma, IndiaMedriech Sterilab, India, UK MCA ApprovedAarti Pharma, IndiaRanbaxy Pontasaheb, India, US FDA ApprovedUS Vitamins, India, US FDA ApprovedShreya Healthcare, UK MHRA ApprovedHindustan Unilever LimitedAvon CosmeticsModi Revelon Pvt. Ltd.Oriflame India Ltd.Procter And Gamble India Ltd.Godrej Industries IndiaMather And PlattMrs. Bector Food Specialities Ltd.Mylan India Pvt. Ltd.

DOMESTIC

Glaxo Smith Kline, AustraliaBSP, ItalyNicomac, ItalyKotra Pharma, MalaysiaDuo Pharma, MalaysiaDabur, Egypt/NepalResmed Pharma, South AfricaUS Pharma Inc., USASindan Pharma, RomaniaOman Pharma, OmanKina Pharma, GhanaMay & Baker, NigeriaMentholatum, NigeriaEnaleni Pharmaceuticals SouthafricaSoap And Chemical Trading Corporation, Sharjah, UAESigma Pharmaceutical Pvt. Ltd., AustraliaLipa Pharma, Sydney, AustraliaGulf Processorsand many other Installations…….

OVERSEAS

Containment

• Isolators are usedTo protect the product from the operator and the environmentTo protect the operator from the productTo protect both the product and the operator

• Isolators find use inNuclear EngineeringHospitalsFood industryAnimal LaboratoriesRadioactive Hazard ContainmentMicrobiological Safety

• ApplicationsPharmaceutical Applications

API/Formulation Applications- All standard processes

Research & Development Processes- Handling materials with unknown & limited safety data

Bulk Solids Handling

Sterility Test Isolators- Aseptic environments to remove the chance of human contamination

Sterile Processing- Advantages in quality, safety and cost by replacing traditional clean-rooms with

micro production environments based on isolators.


Isolators

Barrier Isolation Technology

Containment

• Product & Process Protection– Micro-organisms/Particles/Water vapour/Oxygen/Cross-contamination.

• Operator Protection– Toxic chemicals (solid, liquid or gas)/pathogenic micro-organisms/genetically

engineered material. • Operator and Product & Process Protection

– The isolator is an ideal system for achieving these dual and normally opposing objectives. Depending on the greater of the two demands positive or negativepressurisation used.

• External Environment Protection• Security

– The relative smaller scale of an Isolator can be more effectively monitored and is more able to control environments that require high levels of assurance of performance and control of environmental parameters.

• Cost– The use of isolators can considerably reduce the civil, air conditioning and operating

costs associated with traditionally designed facilities.• Cleaning & Disinfection

– The ability to minimise the volume of a critical environment also reduces the surface areas requiring cleaning and these chemicals can be handled more safely in an isolator environment.

INTEGRATED EQUIPMENT & PROCESSES

IN

TRANSFERIN

TRANSFEROUT

STERILIZESAUTOCLAVESTUNNELSOVENS

CONVEYORSISOLATORSPASS BOX

PASS BOXRAPID TRANSFER PORTSPLIT BUTTERFLY VALVEBAG TIE TECHNIQUES

MANIPULATION

OUT

ENCLOSURE

VENTILATION& FILTRATION

POSITIVE/NEGATIVE

TURBULET/NON-TURBULENT

AIR CHANGES & GLASSIFICATION


Objectives

BLOWER

EU 13 OR 14

EU 13 OR 14

NEGATIVE

%

OUT

BLOWER %

IN %

EU 13

EU 13

WORK SURFACE

CG SCREEN

POSITIVE

EU 13


Containment

Containment Strategy

Select Exposure Potential

• Step 1

Select occupational exposure band

• Step 2

Select contamination control strategy• Step 3

EXPOSURE

POTENTIAL

SELECT BAND SELECT CONTROL STRATEGY

<0.01µg/m3

1-0.01µg/m3

10-1µg/m3

100-10µg/m3

1,000-100µg/m3

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy10,000-1000µg/m3

A

B

C

D

E

F

1

1

1

2

3

4

3

2

1

2

3

3

5

4

3

1

2

3

4

5

4

4

2

3

4

4

5

5

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Control Strategy

Dustiness Potential

QuantityHandled

smallgms

mediumgms

highgms

Short

Long

medium high

Ep2

Ep3

Ep4

Ep2

Ep3

Ep3

Ep3

Ep4

Ep4

low

Ep1

Ep1

Ep2

Ep1

Ep2

Ep3

Ep1

Ep2

Ep3

Exposure LimitRange

SOLIDS

Exposure LimitRange

LIQUIDS

Hazard Band

Control Strategy 1Local Exhaust Ventilation

Control Strategy 2Directional Airflow Booths

Control Strategy 3Glove Box lsolators & Hybrid Booths

Control Strategy 4lsolation & Direct Connections

Control Strategy 5Robotics or Remote Operation

A

B

C

D

E

F

500-50 ppm

50-5 ppm

5-0.5 ppm

0.5-0.05 ppm

0.05-0.005 ppm

< 0.005 ppm

310,000-1000 g/mµ

31,000-100 g/mµ

3100-10 g/mµ

310-1 g/mµ

31-0.01 g/mµ

3< 0.01 g/mµ


EXPOSURE

POTENTIAL

EXPOSURE

POTENTIAL

EXPOSURE

POTENTIAL

Select ContainmentTechnology

• Step 4


Containment

Double door transfer port ,by careful mechanical design and manufacture, used to make immediate transfers without break of containment. Typically 100mm to 350mm in diameter.

Port flange known as the active port and bolted to the wall of the isolator. Port door that closes into the port flange and carries a special arrowhead seal.

Container flange known as the passive port and fitted to the front of a mobile container and carries a further arrowhead seal. Containers can be plastic/SS drums or bag ports or other isolators.

Container lid that closes the container. Rotate and non-rotate docking designs exist.

The two doors are interlocked to ensure that the active is locked when the passive is detached. The design brings the two arrowhead seals together point to point to minimise the potentially contaminated area around each seal. Known as the ring of risk or confidence and thus this should be carefully wiped for cleanliness/protection/decontamination/damage limitation prior to docking.

The reliability of the containment system therefore depends on the condition of these seals and this depends on their treatment and the care taken in docking.

Transfer Devices



Rapid Transfer Port - RTP

Split valve, by careful mechanical design and manufacture, used to transfer powder without break of containment. Typically 100mm to 300mm in diameter.

Half valve known as the active and bolted to the wall of the isolator. Container half valve known as the passive and fitted to the Intermediate Bulk Container

The design brings the two part valves together face to face to minimize the potentially contaminated area around each seal. However there is a small release of powder when the valve is split.

Split Butterfly Valve

The reliability of the containment system depends on the condition of the inner seal for the valve and depends on the treatment of the valve and the care taken in docking.

Containment

For 2Kg and 5Kg batch sizes; an off the shelf solution to your contained granulation requirements.

Isolator designed to provide containment (OEL to 0.1µgm/m3) for wet granulation of potent products.

This isolator is a single chamber unit integrated with a Weigh Balance, Rapid Mixer Granulator, Fluid Bed Dryer/Processor, Mill and Bin Blender. Isolator is provided with a Pass Box Chamber, Rapid Transfer Port, 2 Gull-Wing doors and a Wash in Place system. The isolator operates at a negative pressure with 20 air changes per hour and in the case of a containment breach the system will alarm and provide ‘in rush’ protection. The design has been ergonomically tested to ensure that the intended operations can be easily performed and is fully GMP compliant. The system operates on SCADA interface.

Granulation Isolator


Our Offerings

Containment

Our Offerings

Bectochem has had prior experience in installation of granulation suites single or adjacent processing rooms. The equipment layout is based on a through-the-wall design to minimize processing space and simplify cleaning the equipment.

Bectochem provides the complete granulation suite system, including gravity charging into the high shear granulator, transferring through a wet mill to the fluid bed dryer, and gravity discharging the fluid bed through a dry mill and into an IBC. Gravity is utilized to provide a more efficient flow of product. The product transfers are achieved through Split Butterfly Valve integrated with the equipment.

High Containment Granulation Facility

Dispensing & Sampling

Dispensing and sampling of the potent raw material is done through isolator. The sample is sent to the QC in a contained fashion and the desired quantity is dispensed in IPC Bin docked to the isolator.

Granulation The Process equipment within the suite is high speed or Rapid Mixer Granulator [RMG], a wet mill, a Fluid Bed Dryer and a dry mill; all operating using Split Butterfly Valves & Gravity Feed.

IPC Bin is brought into the suite & hoisted above, docked via Split Butterfly Valve and the powder loaded into the RMG. The Binder is added either through peristaltic pump or from kettle through glow


After the granulation process is complete, the mixer relies on gravity and a wet mill to control the product flow into the fluid bed dryer. Fluidization is maintained throughout the transfer process to assist product movement and to reduce clumping defects.

After the fluid bed drying process is complete, product is discharged via rotating product screen through the actuated valves. The dried product is discharged into an intermediate hopper where it waits to be dry milled and then into the final Blender Bin. The bin is sent for blending.

Containment

Objectives Achieved

Optimization of the floor space, giving particular attention to the layout, personnel and materials flow. This reduces capital costs of HVAC, utilities, building finish as well as building, civil and structural costs.

Grouping of manufacturing operations and linkage of process equipments, wherever possible. This helps in optimizing yields, providing quality issues feedback quickly and meeting OEL requirements.

Usage of gravity feed, and flow bin systems. This reduces labour costs, optimizes yields, minimizes cross contamination and meets OEL requirements.

Careful design of containment systems.

Clean-In-Place (CIP) & Wash-In-Place (WIP) systems.

Equipments designed for quick changeovers and easy to clean.

Our Offerings


High Containment Granulation Facility

Containment


Our Offerings

An aseptic Class-A environment for the sterility testing of sterile products, providing levels of sterility assurance, at a cost advantage, not possible with traditional clean room sterility testing methods; models available with pass b o x , w i t h i n t e g r a t e d b i o -decontamination unit for the surface treatment of components with vapourised Hydrogen Peroxide and for the handling of toxic products. The machines are ergonomically tested and fully GMP compliant.

Sterility Test Isolator

• Integrated bio-decontamination chamber for the transfer of all product/materials/ components into the Isolator. These are held in a standard load configuration during thecycle.

• The main isolator chamber operates at positive pressure with EU14 HEPA filteredre-circulated air providing a non-turbulent class A airflow at the work zone. Constructed inSS316L with fully GMP compliant design.

• PLC controlled, Integrates with proprietary makes of Vapourised Hydrogen PeroxideGenerator.

Features

Isolator vs. Clean-room

Bio-Decontaminataion Chember Integration ofSteritest Equipment

Inflatable door seals

Containment

Bringing Innovation in Powder Handling

of Bulk Solids Handling

DrumSampling

Continuous Filling Liner

LBKQ-DOS Metering System

Closing Toolkit

The World

Containment


HALLMARKS IN ISOLATION TECHNOLOGYThe investments made by our company in people and facilities for the past decades have yielded a proud history of innovations in many forms of processing.

For Example In Isolation Technology Solids and Liquids Processing R&D Testing Laboratories.

Some of the major achievements by the

organization in the Isolation technology arena have been :-

2004 ACE Tie Up• First Negative Pressure Isolator Delivered and Commissioned

2006• Inhouse development of Rapid Transfer Port and Split Butterfly Valve

2008• Launched new Range of Granulation & Sterility Test Isolators• Launched High Containment Granulation facility

To date• Capability - full range of positive & negative isolators• Isolators validated by Mylan India, GSK, Pfizer, Sandoz, Dr. Reddy’s Laboratories• 300+ Isolators Installed and Commissioned

5C / 204, Mittal Industrial Estate, Andheri Kurla Road, Andheri (E), Mumbai - 400 059. INDIA. +91 (22) 850 0008, 850 2400, 850 0057Fax : +91 (22) 850 6785 Email : [email protected]

BectochemConsultants & Engineers Pvt. Ltd.

Containment Brochure '09

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