Bio Pharma | Vaccines | Sterile Formulations

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.

Features

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
  • QbD
  • 3D Modelling
  • Plant equipment layouts

Qualification

  • Testing, qualification and documentation services
  • Qualification (IQ / OQ)
  • HAZOP

Automation

  • 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

Smart Facilities

  • 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

Technical Specifications

Mechanical

  • 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
  • Contact material: 316 L, Hastealloy andother higher alloys
  • Agitator systems as per process requirements
    • 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

Instrumentation

  • Sensors and transmitters for temperature, pH, PO2, Level, Conductivity, Pressure, Flow, etc.
  • Weight measurement using load cells

 

Processes

  • 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

Installation

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.

Qualification

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).