Our sterile systems are designed to be 100% cleanable and are free from dead-leg areas. To ensure that our products offer consistent quality, we use high precision components integrated with a fully automated and intelligent control system and a full cGMP documentation package.
Codes and Standards
cGMP / FDA
Designed as per ASME / PED
Manufactured in compliance with ASME BPE or cleanability&sterilisation
ASME U-Stamp (optional)
21CFR Part 11compliance
Design and Manufacturing
PFD and P & ID development
Plant equipment layouts
Testing, qualification and documentation services
Qualification (IQ / OQ)
Programming in accordance with S88
Intelligent Automation in accordance with GAMP
Local Control system for operation with HMI / IPC
Optional communication with external SCADA / MES / MIS
Batching systems with EBMR
Dedicated FAT centre with testing bays which are fully equipped with utilities such as Clean Steam, Hot and Cold DI Water, CIP, Plant Steam, Compressed Air, Filtered Process Air, Chilled Water, etc.
Fully equipped with instruments and testing equipment to simulate the conditions at the customer’s site
All skids are fully tested and qualified
All pre-FAT reports are available for customer prior to FAT visit
Open framed / Skid systems for easy cleanability and maintenance
Space conserving design
Working volumes ranging from 80 mL to 45,000 L
Systems include options for integration of other bioprocess systems
Aspect Ratio H/D as required
Surface finish –
Process contact: Ra ≤0.4 μm; e-polished
Non-process contact: Ra ≤0.8 μm
Satin / Mirror finish with rounded corners
Internal and External Pressure: –1 / +5 bar
Temperature: -10°C / 130°C
Jacket with spiral guide, half pipe, dimpledwith heat exchangers (optional) for precisetemperature control
Top mounted / bottom mounted with mechanical / magnetic couplings
Double mechanical seal or magnetic drive
Exhaust system with optional cooler and heater, sterile filter and pressure control
Valve groups for the addition of media and corrective agents, sampling, harvest
Additional autoclavable vessels
Sensors and transmitters for temperature, pH, PO2, Level, Conductivity, Pressure, Flow, etc.
Weight measurement using load cells
Independent CIP / SIP of vessel and components including Filter assembly, Sampling System, Outlet Valve, Inlet Ports, transfer lines, etc.
Sampling System – Reusable / Single use bag
On completion of the Factory Acceptance Test (FAT), the equipments, components, instruments, etc. are packed in transport worthy packing and items are duly labelled for easy identification at site.
DDE’s site team is mobilized to ensure efficient and least instructive installations, which would involve the following activities:
Verification during unpacking for ensuring no damages in transit
All parts i.e. equipments, components, instruments etc. are verified with packing list in order to ensure no shortages
Supervision of installation of the system at the desired locations
The pipelines etc. are connected and the instruments are fixed to the systems, as per P & ID and 3D Layouts, which forms a part of Design Qualification Documents (DQ)
The Site Acceptance Test (SAT) “Pre- checklist” is verified for the following typical checks, thereafter to be handed over for Qualification:
The electrical & system communication connectors are in line with the “Electrical Architecture” & “System Architecture”
All required utilities are available
All required solutions / instruments are available for conducting the SAT Qualification
The SAT Installation Qualification (IQ) & Operational Qualification (OQ) protocols have been signed off by the concerned departments.
Commissioning & Qualification
Our experienced Commissioning and Qualification team have the technical skills required to ensure successful handing over to the customer for initiating process qualification activities.
A well planned documented and managed engineering approach is used, that results in a safe and functional environment that meets established design requirements and stakeholder’s expectations.
Qualification is usually carried out by conducting the following actives, individually or combined.
Design Qualification (DQ)
Documented verification that the proposed design of the equipment or systems is suitable for the end use
The tests and verification required to be undertaken during commissioning is documented in “Equipment Qualification Plan” (EQP), which is approved by the end user prior to commission with IQ & OQ qualification activities. EQP would indicate the verification and tests to be carried out during SAT IQ & OQ.
Installation Qualification (IQ)
Documented verification that the equipment or systems are installed or modified.
Operational Qualification (OQ)
Documented verification that the equipment or systems, perform as intended throughout the anticipated operating ranges (An interactive SOP, comes with the IQ/OQ protocol and on completing the requirements specified in the SOP, the IQ / OQ protocol is completed).
76/1, M.I.D.C. Bhosari,
Pune - 411 026, Maharashtra, India
Ph: +91 (20) 2712 2514 / 5 / 6 / 7