How We Do It

World Class Manufacturing


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".


PURPOSE DESIGNED FACILITY

"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 the new sterile production plant, materials can always be moved from one production stage to the next via the shortest route. The material follows the most efficient route, the personnel the safest one. All movements of materials and personnel within the sterile facility are minimized and organized in such a way that contaminations of the end product are eliminated from the outset.


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 creating two different blocks, one dedicated only to aseptic processing and preparatory work ( Block A ) and another for ancillary activities i.e. Warehouse, Secondary & Tertiary Packing Operations, Quality Control, Quality Assurance and Administrative Area. Both blocks are connected by completely closed corridor. What applies to the production block itself also applies to its connection to existing buildings including the organization of the complete value chain.


Short ways, reduced interim storage and optimized material flow reflect the entire production layout of Immacule Lifesciences. At operational level they are supported by measures for optimizing value stream and increasing efficiency. Maximum flexibility, reliable quality of products and services at the best cost-performance ratio that is what Immacule means when talking about "value for customers".


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 wellbeing 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 highperformance 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 0 motion at a temperature of NMT 25 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.


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.

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