药品生产新设施设备的设计

The design principle is to keep ALL surfaces flush and minimise horizontal surfaces
Good operating practice
Process containment enables Reactor area to be maintained in a clean condition
Flush & effective lighting
LEV
Safety Shower
Room is enclosed with a GMP high standard of room finish
Although Process is fully contained, breathing air supplied (for emergency or cleaning)
• There is also an opportunity to achieve world class manufacturing facilities by considering the design carefully and operation carefully.
Workshop No 6 as example
– Enclose & minimise Room area for each separate unit operation – Provide HVAC – Separate Dispensing / Process & Service / Supply / Waste Areas
• Consider the ability to perform maintenance in Service areas • Consider contained clean-in-place in Process area • Contain wash water so that the plant is kept dry (to minimise corrosion)
• Eliminate cross contamination and cleaning issues
• Design-in process automation:
– Eliminate operator intervention – Design in Quality monitors & EHS controls
Process is fully contained, so operators do not need further protection
Contain Powder addition (from a dispensing area)
LEV provided as back up only
Only combine reactors where necessary
• (e.g. Sampling / Glass thermometers)
– Perceived / actual Quality & EHS issues
• Building finishes:
• Difficult to clean & maintain
Design Concept
• Plant area:
New API Facility Design
Russ Ryan Danhill Consultants
April 2010
Introduction
• Ensky & SW No 2 are undertaking a significant capital spend, primarily to achieve International GMP compliance.
• Building finishes:
– High GMP standard
Design Concept
HVAC
Control HVAC
Packing
Dispensing &
Addition
Services &
Supply
Reaction
Centrifuge/ Drier
Services & Waste
• Lack of process containment resulting in:
– Operator exposure & manual handling [EHS issues]
• Lack of process automation resulting in:
– Manual operation & intervention
Current Key Issues
• Open plant area resulting in:
– Corrosion [loss of assets] due to materials and high ambient RH – Difficult to clean & maintain – No separation of unit operations – Potentially inhibits flexible operation
Minimise pipe-work in reactor area
Process Control Automation [Could be located in a central room]
Some Examples:
• The following examples of facilities & Service suppliers may help to “visualise the vision”.
Fixed fire extinguisher system
HVAC
External Services
– Use aFra Baidu bibliotekpropriate materials of construction & perform DQ
• Design-in process containment:
– Eliminate Operator exposure & manual handling – Contain process inputs and waste [including washing water]