Immacule

CMO of Lyophilised and

Liquid Injectable Formulations

Immaculé
Immacule
Works
Village Thanthewal, Ropar Road, Nalagarh, Dist. Solan, HP-174101 India
Tel. : +91 1795 331401-03 Fax : +91 1795 331400
Email ID: info@immacule.in
 I M VISION
I M EXCELLENCE
I M FUNCTION
I M EFFICIENT
I M SAFETY
I M RELIABILITY
I M QUALITY
Introduction
Immacul
Our Background
Acme Formulation (a renowned name in Indian Pharmaceutical
industry in contract development and manufacturing pharmaceutical
products) and SRS Pharmaceuticals (a leading export house based out
of Mumbai and having strong international presence in innovative drug
product) entered into an alliance to create a world class sterile facility to
cater to global market consummating into creation of Immacule
Lifesciences Pvt. Ltd.

A functional building, the latest innovative clean room technology, “state

of the art” equipment and most modern process design integrated into
the new Immacule's sterile production plant, a production plant which is
one-of-a-kind in India!
VISIONARY STERILE PRODUCTION PLANT
Our vision was to build a production plant that combines
functionality and aesthetics with efficiency and safety to a
harmonical ensemble. Maximum transparency and
openness for customers and authorities, a bright, friendly
and agreeable work place for our employees and
uncompromising pharmaceutical quality for the
consumers were our mission statements for this plant.
Here, people work for people, our employees create
values for customers and consumers committed to
Immacule's motto “Focusing on people”.

Fast Track Project

In 2012, we began planning a new sterile production
facility which let our vision become reality. Only two and
half years later Immacule Lifesciences was granted the
manufacturing license for a highly innovative and flexible
sterile production plant that intends to produce sterile
pharmaceuticals for all over the world with state of the art
technology. The facility is the solution to today´s global
customer and market needs and already complies with all
the requirements that will enable it to adapt flexibly to
future demands.
OPERATIONAL EXCELLENCE
Operational Excellence, Lean Production, continuous improvement, these are the keywords that cross one´s mind
when it comes to the question on how a company can sustain its position in competition with others. Because
nowadays it does not suffice to be good any more, who wants to stand one´s ground in the competition must stand
in the forefront, just as Immacule when it comes to Operational Excellence.
Immacule's new sterile facility is intended to implement exemplary state-of-the-art management techniques in order
to improve operational performance potential, promote excellent quality and achieve competitive manufacturing
costs.
At Immacule, these objectives have been pursued from the planning of the new sterile plant to its implementation as
a whole. The layout of the new sterile plant has been designed in such a way that the production process is supported
in an optimal manner. To achieve this, materials flow in the new sterile facility have been simulated during the
planning phase to prevent any form of waste of capacities, personnel and material resources, area or time. On the
basis of these considerations a plant layout has been designed that allows a standardized work flow and increases
employees´ productivity while at the same time it decreases the risk of contamination.
Standardization and reduction to the absolutely necessary, are the basic requirements for a lean production. At
Immacule the construction and installation of machinery and equipment was accordingly done on the basis of
extensive process simulations and work analyses. As a result, each work station is designed ergonomically so that PURPOSE DESIGNED FACILITY
each hand motion can be carried out in a standardized and efficient manner that ensures a smooth process and saves
valuable production time, and therefore costs. “Space and Light and Order .. Those are things that men need just as much as they need bread or a place to sleep”
quote from famous French Architect Le Corbusier who designed city of Chandigarh which is 60 kms from facility,
has served as inspiration for defining architecture of Immacule.
The result is a sterile production plant that is perfect in functionality, efficiency and flexibility.
Committed to the guiding principle “value for customers” Immacule's project team made sure that from the first draft
of the building, up to the initial operation, a plant layout was created that combines reliable product quality,
pharmaceutical safety and efficient manufacturing with a anticipatory development planning and flexible order
processing.
Now it is possible to manufacture development batches of 10 liters as well as manufacturing campaigns with up to
500 liters scheduled quantity. This applies both to terminal sterilized and aseptically manufactured products. Future
regulatory requirements have been anticipated and taken into account during the planning of the new sterile
production plant. Based on theoretical simulations the layout of the plant has been engineered for optimum work
flow.
With No Detours
Using integrated pass-through and hatches in Short ways, reduced interim storage and
the new sterile production plant, materials can optimized material flow reflect the entire
always be moved from one production stage to production layout of Immacule Lifesciences.
the next via the shortest route. The material
At operational level they are supported by
follows the most efficient route, the personnel
measures for optimizing value stream and
the safest one. All movements of materials and
increasing efficiency. Maximum flexibility,
personnel within the sterile facility are
reliable quality of products and services at
minimized and organized in such a way that
the best cost-performance ratio that is what
contaminations of the end product are
Immacule means when talking about “value
eliminated from the outset.
for customers”.

Customized Layout of The Plant

Immacule's project team was always of
opinion that access to aseptic areas should
be minimal and it is amply achieved by Block A Block B
creating two different blocks, one 1 Dispensing 1 Warehouse
 ( RM/PM/ FG)
dedicated only to aseptic processing and
1 Compounding 1 Secondary /Tertiary Packing
preparatory work ( Block A ) and another 1 Sterile filtration 1 Quality Control Laboratory
for ancillary activities i.e. Warehouse, 1 Filling 1 Quality Assurance Cell
Secondary & Tertiary Packing Operations, 1 Terminal Sterilization 1 Documentation Cell
Quality Control, Quality Assurance and 1 Lyophilization 1 Training Cell
Administrative Area. Both blocks are ( Automatic loading and unloading system)
1 Visual/Autoinspection 1 Administrative Area
connected by completely closed corridor.
1 Labelling 1 Stability Cell
What applies to the production block itself 1 Packaging 1 Cafeteria/Canteen
also applies to its connection to existing Pilot Manufacturing Plant
buildings including the organization of the 1 Service Floor
complete value chain. ( AHU/PW/WFI/Pure Steam/Nitrogen/BMS)
STRUCTURE & EFFICIENCY
The construction of a production building in uncompromising consideration of functionality and efficiency requires
not only expert knowledge and professional competence but also many years of experience in organizing and
controlling complex and cross-linked processes, at Immacule experienced partners, a professional project
management and a highly motivated, competent project team were involved in its realization.
The planning of the plant layout designed for functionality and efficiency is continued consistently in how the actual
heart of the sterile production plant has been conceived. Both the clean room concept and the configuration of the
production lines have been implemented in an entirely functional way.

Maximum Pharmaceutical Safety and Efficient Processes

In Immacule sterile production plant, differentiation is generally made between four clean room classes in which
certain particle counts are permitted and consequently appropriate gowning procedures are required. The personnel
lock system that links all the different clean room classes together is designed to allow for standardized procedures .
At the same time the design of the clean room classes is functionally geared to an optimized work flow. Thus the
necessity of passing in and out through personnel locks is minimized. As a result efficiency is increased, the risk of
contamination is reduced.

Coherence
The clean rooms surrounding each filling line are designed in an almost identical layout. As a result there are hardly
any differences or changes in the production process for personnel when working on the different lines, work
processes can be standardized and consequently carried out safely and reliably.

Efficiency by Design
The principle of lean production has been amply implemented while arranging the filling lines. Machines are set up in
such a way that the space needed for the highest clean room class is optimized and increases the employees
productivity. Starting from decartoning of vials/ampoules to washing, heat sterilization, aseptic filling , sealing, vials
loading , unloading , crimping, inspection and labeling are laid down in linear fashion, hence optimizing productivity
and minimizing risk of cross contamination. Access to all areas are through biometrics for personnel and dynamic pass
boxes are placed for material transfer across the facility.
TRANSPARENCY & SAFETY
Looking at, on, in and out. Using glass as the dominant
construction material provides insight and vision. At
Immacule the conscious decision has been made; because
he who has insight can understand and he who has view can
manage.
What employees appreciate in a green building is ample day
light and surrounding green space.
In the truest sense of the word the transparent production
plant demonstrates openness, clarity and transparency
towards customers, authorities and employees. And this is
also true for the product. In the filling of sterile liquid dosage
forms the raw material glass is still the dominating material
for packaging.
Transparent Process
Within the scope of audits glass walls make it possible to
monitor all manufacturing processes without having to enter
the clean rooms. As audits are carried out frequently in the
contract manufacturing industry this can contribute
significantly to an improved drug safety. In the sterile
production plant glass is therefore used over large areas
especially in the interior clean room area.
Full Communication
The generous use of glass surfaces enables the employees
who work in the sterile production plant not only to follow
and track the production sequence, but also to communicate
with one another during the production process without
having to leave the work area. The glass sterile production
plant offers a view and link to the outside and with the
daylight that conversely it lets in, it contributes to the well-
being of the people who are working there. For continuous
monitoring of aseptic processing area CC TV and video door
phones are fixed.
Technology & Reliability
Confidence is based on reliability and being reliable depends on meeting expectations. High end
technology, high level of employee qualification and modern process design are the
characteristics which Immacule develops continuously and which it intends to prove time and
again within the scope of international audits.
Immacule aims to produce significant volumes of sterile product from this brand new facility to meet
the increasing demand for the company´s services in the area of contract manufacturing. Immacule
not only aims to produce more and faster but with consistent safety and reliability.

Aseptic Area
All aseptic operations ( filling, sealing, rubber bunging, lyophilizer loading - unloading and vial crimping) are all
carried under ISO class 5 ( class A clean room) and background area is as per ISO class 6 ( class B clean room).
PERFORMANCE & QUALITY
Anyone wishing to offer the highest product quality must ensure
that the product process is faultless and this requires a high-
performance production plant. In the new production facility
Immacule Lifesciences integrates machinery, equipment and
technology at the latest “state of art”.
A further technical highlight within the new sterile production plant
is the enhanced supply with high purity media, sterile air, ultra-pure
steam and water for Injections.

Purified Water System

Purified water system generator treats soft water through
sequential filtration operation of Ultra filtration, 2 pass Reverse
Osmosis followed by Electro De ionization and generates within one
hour 3000 liters of HPW (Highly Purified Water). From this 1000 liters
of WFI is generated which is used to produce 1000 kg of ultra pure
steam each hour, for sterilizing production batch and filtrate
containers, the filling lines, autoclaves and all the machine parts that
come into direct contact with the product. pH, conductivity,
temperature and TOC is determined and controlled online by highly
sophisticated sensors and actuating controlling mechanism. All
control panels and PLC are complying with GAMP.
To keep the distribution system of feeds, pipes, connectors and
valves between the water processing and filling lines reliably sterile,
Immacule has realized the entire water processing and distribution
in the form of a loop system. In this loop water is continuously kept in
motion at a temperature of NMT 250 C
Filtered Air
24 AHU's are designed and installed with references from ISO 14644,
ISPE, EU guidelines. TFA is used to reduce particle contamination
through external air and to reduce the outside latent load. System is
monitored and controlled through fully integrated BMS. AHUs are
placed in technical area having epoxy flooring & distribution ducts are
directly accessible for examination and maintenance via a walk-in
clean room ceiling.
CAPACITY*
*( Based on 2 ml fill volume, can vary based on actual fill volume and cycle time)
GO GREEN
The built environment has a vast impact on the natural environment, human health, and the
economy.
By adopting green building strategies, Immacule has maximized both economic and
environmental performance. Green construction methods were integrated into buildings at
all stages, from design up to finishing of construction. Few highlights are terraced garden,
usage of LED, solar panels for generating 25 KVA power, steam recovery units, reusing
treated effluents for domestic use and horticulture, using maximum glass to improve natural
light across facility to save power etc. are measures we make in our effort to support our “
GO GREEN” mission.

TYPE PRODUCT Qty/Annum

Vial Lyophilized 12 million
Liquid 24 milliion
Total 36 million
Ampoule Liquid 36 million