Bectochem

Consultants & Engineers Pvt. Ltd.

Containment

www.bectochem.com 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 Bectochem, now approach you to develop a mutually beneficial relationship, a relationship
that would last for years to come.

R. M. Bector
Chairman

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COMPANY PROFILE

Bectochem
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.

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

The offices are in Australia Germany China UK Egypt USA

Bangladesh Pakistan Israel Italy Russia UAE

In India, the associates are in

Ahmedabad, Bangalore, Hyderabad, Chennai, New Delhi

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COMPANY PROFILE

1978
Bectochem
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 Serve

Pharmaceutical
API Manufacturing
Solids Formulations
Liquid Formulations
Ointment Formulations
Research & Development
Food
Cosmetics
2009

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.

Mission “To be an innovative process engineering company catering to a global

market with Dynamic, Proactive, Customer driven approach”

Vision
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

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COMPANY PROFILE

HALLMARKS
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 the
leader 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 fully
functional 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.

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CLIENTELE

OVERSEAS
Glaxo Smith Kline, Australia
BSP, Italy
Nicomac, Italy
Kotra Pharma, Malaysia
Duo Pharma, Malaysia
Dabur, Egypt/Nepal
Resmed Pharma, South Africa
US Pharma Inc., USA
Sindan Pharma, Romania
Oman Pharma, Oman
Kina Pharma, Ghana
May & Baker, Nigeria
Mentholatum, Nigeria
Enaleni Pharmaceuticals Southafrica
Soap And Chemical Trading Corporation, Sharjah, UAE
Sigma Pharmaceutical Pvt. Ltd., Australia
Lipa Pharma, Sydney, Australia
Gulf Processors
and many other Installations…….

DOMESTIC
Glaxo Smith Kline R&D Facility, Nashik, India
Sandoz, India
Dr. Reddy’s Laboratories, India, US FDA Approved
Aurobindo Pharma Ltd, India, UK MCA Approved
Dabur India Ltd. Now Fresenius Kabi – US FDA, UK MHRA Approved
Natco Pharma Limited, India
JB Chemicals, India, MCC Approved
Elder Pharma, India
Medriech Sterilab, India, UK MCA Approved
Aarti Pharma, India
Ranbaxy Pontasaheb, India, US FDA Approved
US Vitamins, India, US FDA Approved
Shreya Healthcare, UK MHRA Approved
Hindustan Unilever Limited
Avon Cosmetics
Modi Revelon Pvt. Ltd.
Oriflame India Ltd.
Procter And Gamble India Ltd.
Godrej Industries India
Mather And Platt
Mrs. Bector Food Specialities Ltd.
Mylan India Pvt. Ltd.

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Barrier Isolation Technology

• Isolators are used

To protect the product from the operator and the environment
To protect the operator from the product
To protect both the product and the operator

• Isolators find use in

Nuclear Engineering
Hospitals
Food industry
Animal Laboratories
Radioactive Hazard Containment
Microbiological Safety

• Applications
Pharmaceutical 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
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Barrier Isolation Technology

Objectives
• 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 negative
pressurisation 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.

BLOWER

INTEGRATED EQUIPMENT & PROCESSES

EU 13 OR 14
VENTILATION
& FILTRATION

TRANSFER POSITIVE/NEGATIVE TRANSFER

NEGATIVE IN TURBULET/NON-TURBULENT
OUT
AIR CHANGES & GLASSIFICATION

STERILIZES
AUTOCLAVES
EU 13 OR 14 TUNNELS CONVEYORS
OVENS ISOLATORS
PASS BOX

IN OUT

OUT
ENCLOSURE
RAPID TRANSFER PORT
EU 13 PASS BOX SPLIT BUTTERFLY VALVE
BLOWER % BAG TIE TECHNIQUES
% MANIPULATION
IN %
EU 13

POSITIVE
CG SCREEN

WORK SURFACE

EU 13

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Barrier Isolation Technology

Containment Strategy
• Step 1 • Step 2
Select Exposure Potential Select occupational exposure band
Dustiness Potential Exposure Limit Exposure Limit Hazard
Range Range Band
Quantity low medium high SOLIDS LIQUIDS
Handled 10,000-1000 µg/m3 500-50 ppm A
small Ep1 Ep1 Ep2
1,000-100 µg/m3 50-5 ppm B
gms Ep1 Ep2 Ep3
100-10 µg/m3 5-0.5 ppm C
medium Ep1 Ep2 Ep3
gms 10-1 µg/m3 0.5-0.05 ppm D
Ep2 Ep3 Ep4
high Ep2 Ep3 Ep3 1-0.01 µg/m3 0.05-0.005 ppm E
gms Ep3 Ep4 Ep4 < 0.01 µg/m3 < 0.005 ppm F

Short
Long

• Step 3 Select contamination control strategy

EXPOSURE EXPOSURE EXPOSURE EXPOSURE

1 POTENTIAL 2 POTENTIAL 3 POTENTIAL 4 POTENTIAL
SELECT BAND SELECT CONTROL STRATEGY

F <0.01µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

4 5 5 5

1-0.01µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

E 3 4 4 5

10-1µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

D 3 3 4 4

100-10µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

C 2 3 3 4

1,000-100µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

B 1 2 2 3

10,000-1000µg/m3 Control Strategy Control Strategy Control Strategy Control Strategy

A 1 1 1 2

• Step 4
Control Strategy 1 Control Strategy 3 Control Strategy 5
Select Local Exhaust Ventilation Glove Box lsolators & Hybrid Booths Robotics or Remote Operation
Containment
Technology
Control Strategy 2 Control Strategy 4
Directional Airflow Booths lsolation & Direct Connections

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Barrier Isolation Technology

Transfer Devices
Rapid Transfer Port - RTP
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.

Split Butterfly Valve

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.

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.

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Our Offerings

Granulation Isolator
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.

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Our Offerings

High Containment
Granulation Facility
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.

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.

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Our Offerings

High Containment
Granulation Facility

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.

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Our Offerings

Sterility Test Isolator

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
box, with integrated bio-
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.

Bio-Decontaminataion Chember Integration of Inflatable door seals

Steritest Equipment

Isolator vs. Clean-room

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

• The main isolator chamber operates at positive pressure with EU14 HEPA filtered
re-circulated air providing a non-turbulent class A airflow at the work zone. Constructed in
SS316L with fully GMP compliant design.

• PLC controlled, Integrates with proprietary makes of Vapourised Hydrogen Peroxide

Generator.

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Drum
Sampling

Q-DOS LBK Continuous

Metering System Filling Liner

Closing Toolkit

The World
of Bulk Solids Handling
Bringing Innovation in Powder Handling
 HALLMARKS IN ISOLATION TECHNOLOGY
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.

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

Bectochem
Consultants & Engineers Pvt. Ltd.

5C / 204, Mittal Industrial Estate, Andheri Kurla Road, Andheri (E),

Mumbai - 400 059. INDIA. +91 (22) 850 0008, 850 2400, 850 0057
Fax : +91 (22) 850 6785 Email : isolator@bectochem.com

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