D.D. Enterprises (DDE) specialises in Designing, Planning, Manufacturing & qualification of Sterile Process Plant equipments.
The manufacture of drugs and active substances requires very high standards of quality to be maintained with respect to product purity and validated manufacturing processes. We are aware of our responsibility and our work is guided by the standards of the international pharmaceutical industry such as cGMP guidelines and FDA requirements.
Our expertise in the sector arises out of the experience of our engineers and biotechnologists which is reflected in their imaginativeness, creativity and strength in realisation. It provides the guarantee of successful project management. On the basis of tried and tested standards, our project teams devise individual project documentation specific to your individual requirements and deliver the projects on time, within the budget and to the agreed level of quality.
Our Projects team work closely with you in coordination with various functional heads at Ingenesys to ensure smooth and successful completion of your Project.
Bottlenecks are identified early in the project and are solved through a well calculated approach with a minimum amount of time, effort and money. The complete project is managed efficiently right from the initial URS development to after- sales service with strict compliance to agreed quality standards.
Our Team of Microbiologists and Engineers work closely with you by supporting you with the desired technical information for initial URS development. Process Flow diagrams and P & ID's are developed by our Process team in strict adherence to the final URS.
We are here to answer all your queries right from the design of the pipeline system, the size and shape of the vessel to the definition of the scope of documentation.
The main features of our plant, plant layout, functional description, technical specifications, time schedule and documentation are mutually defined during the basic engineering phase.
The Basic engineering phase is followed by detailed engineering. This includes the draft of the P&IDs, layout plan, piping plan, detailed time and production schedules, draft of 3D drawings, material purchase of the highest quality, qualification as well as documentation.
Our designers use the latest Engineering tools like ACAD and Solid Works to engineer and model the systems in accordance with Customer requirements and specifications. The 3D models are used for actual verification of compliance to various standards viz. ASME BPE etc.
Detailed Manufacturing drawings and Isometrics are converted to High quality equipments and skids at our state of the art manufacturing facilities. Our team of qualified and experienced manufacturing personnel ensure that all the details as specified in the drawings are complied with through various stages of manufacturing.
Our quality control department clears the Job as defined in the customer agreed QAP / EQP. Our Production and Quality control managers and supervisors are kept up-to-date with regular training sessions in the requirements of ASME BPE.
Our products and services are offered with customized process plant software that comply with respective customer requirements, provisions and regulations .
The Automation process is based on the User Requirement specifications ( URS ). The basic specifications of the hardware and software are formulated and the documents for FDA and GAMP approval are translated accordingly.
At the end of this phase, clients are aware of what they measure and control as well as why, when and how it is going to be documented and visualized.
We plan detailed functional specification (FS), hardware design specifications (HDS), installation plans, parts lists and wiring diagrams. Furthermore, I/O sheets, Valve Matrix, parameter lists and control panels get their final clearance from us after ensuring it conforms to the desired automation needs.
Our systematic qualification process spans the life cycle of each project, assuring the quality of the systems, and its conformance with the URS.
Our dedicated FAT centre is fully equipped with all utilities, instrumentation and automation to test each equipment / system thoroughly. During Pre-FAT, Equipments are subjected to similar operating conditions as your plant in compliance with an intensive FAT protocol.
We document different design steps in basic and detail engineering phases in order to offer complete traceability of the production process. This is followed by documentation of the material and parts we buy, welding documentation by boroscopy.
The project-specific quality plan (EQP) ensures that design, fabrication, installation, testing, and commissioning is carried out in accordance with all relevant international standards and specifications such as ASME-BPE, GAMP 5, and 21 CFR part 11 to support plant level GMP compliance. The high standard of drawings and documentation generated during the project builds up to deliver the highest standards of documentation hand-over pack allowing for efficient and timely validation of our systems.
We offer our IQ / OQ / PQ documentation in Standard format and if required to customised preferences.
Our documentation has been witnessed by official institutions like the FDA.
After completion of each Project we conduct training of the Customers Personnel during FAT at our dedicated FAT centre and impart Formal training / reinforcement session at the customer's plant during SAT. This ensures that the maintenance staff is also well versed with the system, its components and the automation.