Hi PaulF

Hi PaulF

My head of Regulatory Affairs and Lead Internal Auditers would be fried by the FDA. I was a humble research assistant in those days and was happy to conform to very high standards and receive no ‘yellow perils’.

Production lines in Pharma have evolved to be devoid of human contamination hence accidental contamination can be considered a minimal risk.
I would by that same argument suggest that deliberate contamination (in this case apparently at least two other products) was even less likely. Yet it appears to have happened.

Hypothetical but each tablet/capsule has a low plus/minus tolerance in weight/volume and production line systems can be made (if not in place already) to detect any item that does not conform to tolerance levels and even appearance (identity markers/letters not visualised by micro imaging CCTV). This would normally halt the line automatically requiring a manual override after investigation.

How and at what point did contamination occur?

Are there not likely to be event triggered CCTV footage that would now get reviewed. (e.g. if someone vaults over a ticket turnstile at a rail station good CCTV systems automatically mark the event electronically as abnormal hence assisting review later)

What hasn’t been revealed in this case and may never is whether it was individual blisters that were contaminated in several strips, or an entire strip of blisters, …….

I think a lot should be learnt by Pharma by this scare as the technology is all available and they if any have the money to invest to safeguard their own backs.

Let me give you a parallel example from the microelectronics world. A large very reputable computer server manufacturer used home grown automated quality assurance systems in verifying if each mother board was acceptable. The test programs were home authored and it produced excellent results. Every board was checked at each stage of layering (additional components) and failures went automatically into a potential failed line and went through further checks to see where the failures were introduced. They then were able to identify batches of components or material that caused the failure and deal with supplier issues. Quality was very high on any board that left that manufacturing plant and still is.

Microelectronics by its name suggests items and components many of which are far smaller than most Pharma tablets/capsules and if microelectronics can get it right then Pharma can.

I totally agree it is a mindset, screening and standards of employee quality that also must be upped but the errors at manufacturing in Pharma can be reduced to almost zero.

I also agree with you that ticking boxes isn’t my idea of quality and it’s continuously upping the standards and reducing risk levels that gets things to 100% or near 100%.

Some interesting facts re the 787

Some interesting facts re the 787

http://www.boeing.com/commercial/787family/programfacts.html

The 787 Program covers many areas of interest, from the market, customers, and airplane technology to manufacturing enhancements and an extensive partner team, among others. Here are some interesting facts and figures on a number of these topic areas:

Market Size
3,310 units over 20 years (2009-2028)

Expectation of sales out of 3,500 units
More than half

Major program milestones
• Firm configuration completed – September 2005
• Major assembly began – June 2006
• 787 first flight – December 2009

Seat range of airplane
200 – 300

Seats by model
• 787-8, 210 to 250
• 787-9, 250 to 290

Speed at which it will fly
Mach 0.85 (about the same as a 777 and 747)

787 vs. 777 on composites and aluminum (by weight)
787
– 50 percent composites
– 20 percent aluminum
777
– 12 percent composites
– 50 percent aluminum

Material breakout on 787
• Composites – 50%
• Aluminum – 20%
• Titanium – 15%
• Steel – 10%
• Other – 5%

Example of part count reductions (on first barrel)
• 1,500 aluminum sheets
• 40,000 – 50,000 fasteners (80 percent reduction in fasteners)

Holes drilled into fuselage during assembly
787 – fewer than 10,000
747 – 1 million holes

More fuel efficient
20 percent more fuel efficient than similarly sized airplanes

Produces fewer emissions
20 percent fewer than similarly sized airplanes

Better cash seat miles costs than peer airplane
10 percent

Generators
• Four at 250 kVA (two per engine)
• Two at 225 kVA (on auxiliary power unit)

Hydraulic power
Distributed at:
5,000 pounds per square inch on the 787
3,000 pounds per square inch standard

Advantage of new electric architecture
Extracts as much as 35 percent less power from the engines than traditional pneumatic systems on today’s airplanes

Amount of copper wiring eliminated
60 miles

Design time on computers
800,000h of computing time on Cray supercomputers

Hours of wind tunnel tests
15,000 hours of wind tunnel tests

Size of 787 factory
Approximately 380,000 square feet (380 feet across, 1,000 feet long)

Days the 787 will be in final assembly
The goal is three days

Anticipated maintenenace savings
30 percent

US and non US content on 787
Roughly 70 percent US Roughly 30 percent non-US

Number of Dreamliners Boeing has purchased
4

The number of new city pairs the 787 will connect
At least 450