ISOGEN - Proven Performance through People with a Strong Track Record

Facilities, no matter how beautiful, equipment no matter how "state of the art" do not guarantee flawless performance - People Do!

Isogen starts with the "Right People, Doing it Right" - with many years of experience in implementing advanced barrier and sterile filling in the Pharmaceutical Industry. The experience of our people like Les, Austin, Rob, and the rest of the team has enabled Isogen to design a facility based on a BOD founded on 20+ years of "lessons learned". These 7 critical lessons have been taken to heart and applied to our new facility.

Lessons like:

1. Facility Design:

• Design the facility before the process, don’t allow the facility to drive the process.

2. Ownership and Decision Making:

• Clearly assign system ownership, particularly regarding critical equipment and utility systems. User involvement is key; they are the ones who really know how things function.

3. Process Knowledge & Planning:

• Keep processes simple; careful capacity planning and simulation ensure the utilities and equipment is matched to the process needs.
• Make sure there is sufficient expertise among internal and external project staff.

4. Project Planning:

• General lack of project planning insufficient project planning detail, shortcuts that can lead to significant cost and timing overruns.

5. Project Management:

• Realism is critical, next to poorly defined project scope and detail unrealistic project scheduling and budgeting are the most common causes of projects failing to meet expectations.

6. Bid Process / Documentation:

• Purchase equipment to project need not budget, develop comprehensive bid documentation.
• Under no circumstances use commercial and general terms bid documentation as a basis for validation.

7. Vendor Selection, Communication, Oversight:

• Selection and management of vendors is paramount. Vendors must be capable of delivering not only equipment that can meet the functional specifications in the URS but must also be able to provide critical project documentation (FS / SDS / HDS, etc).
• It is critical that the client needs are clearly transmitted to and understood by the vendor. Asking vendors for the impossible in terms of time or budget will invariable lead to disappointment.
• Under no circumstances ship equipment that does not pass FAT.