designstandards

The issue- We do a lot of things over and over...and it makes no sense
to re-invent the wheel...there is constant pressure to be more efficient, or
even better, more effective...

The obvious answer is to develop design standards...if nothing else, they
provide a starting point to generate the required discussions to arrive at a
Client specific solution...

Design Expertise- In theory, we are experts in our field...this expertise is
based on specific experience with facilties types and industry
expectations...we know what goes into these buildings, how they work,
what they need, even what comes out...

Design Model- Ultimately, this means we should be able to design a
facility with no more than a one or two sentence functional description...

For example...

"Design a cell culture fermentation- purification facility based on a small
scale (1,200 liter) fermenter..."

Beyond this description, we shoiuld be able to produce every other
aspect of the design...obviously, this does not include Client specific
requirments which are essentailly undefined...

Design Standards- what would this standard solution look like? what
document would constitiute the starting point...what details would
complete the project defintion?...

The project Prototype...this should be fun...

Project Scope

Facility Description
Process Description
Equipment List
Architectural General Arrangement
ROM Cost Model

GMP Documents

Material Flow Diagram
Personnel Flow Diagram
Equipment Flow Diagram
Waste Flow Diagram

Standard Design Layouts

Gowning Airlock
De-gowning Airlock
Material Airlock
Material Weigh Dispense Area
Media Prep Area
Buffer Prep Area
Inoculum Lab
Fermentation Area
Primary Purification Area
Secondary Purification Area
Bulk Filling
Glasswash Area
Microbiology Lab
GMP Warehouse Area
Administrative Area

Standard Details

Partition Types and Details
Room Finishes and Details
Door Schedules and Details
Pass Thrus/ Utiltiy Panels
GMP Details
Penetration Details

Project Manual

Outline Specs/ Material Selections by division
Lab Furniture Systems
Fume Hoods/ Bio-safety Cabinets
Weigh Booth/ Laminar Flow Booth
Process Furniture and Storage Systems
Environmental Rooms
HVAC Fixture Cuts
Plumbing Fixture Cuts
Lighting Fixture Cuts
Fire Alarm/ Suppression System Fixture Cuts