autosamplers. For example, take a look at technology like fast
GC or UPLC. With UPLC you can take an HPLC separation which
typically will take 25 to 40 minutes to run and with broad peaks
and you can now shrink that down to a 5 minute run, with very
sharp peaks and better detection and which uses less solvent
– its all around better. We’ve invested very heavily in this tech-
nology and going forward it will all be UPLC.”
Backing up the state-of the-art equipment are very robust
quality control systems. As Hill explains, “We have a full-time
quality manager and a very robust quality system in place.
Because we operate in various industries our quality systems
need to strong. Our base quality system is ISO 9001. Above
that we offer layers of GLP, GMP and DEA licenses."
"We can have one lab that offers ISO level quality and
right next to it one that offers GMP-level quality.”
“While the testing may be exactly the same as far as what
we are doing in the lab, the documentation behind that is
huge, as are safety controls. We also have to have a very
robust training system for people to operate in both modes
and still ensure quality.”
The instrument lab features all new equipment including the latest UPLC equipment designed
to reduce run times, provide sharper peaks, better detection and use less solvent.
In addition to compliance scrutiny from agencies like the
FDA, pharmaceutical service companies like Impact Analytical
are also seeing increased scrutiny from the customer side.
“From the customer we see more scrutiny – because they are
outsourcing more,” says Hill. “If a company wants to contract
with us they need to have the confidence that we will deliver
on all the timelines, costs, but most importantly – the quality.”
“Recently, we have been seeing more people coming
to us saying ‘we have developed this drug candidate but
we want you to do all the analytical work from method
development to validation to release testing – all the way
through’. That’s a bigger relationship than we have seen in
the past and it all centers on trust.”
“Outsourcing is a preferred mode for the pharmaceutical
industry and our forecasts show 3 - 4 years of increased
outsourcing,” says Hill.
MOVING ON OUT
The success of Impact Analytical has resulted in a happy
problem - they have run out of space in their existing facility.
The company is currently in the process of fitting out its
new facility and expects to have it fully functional in a matter of weeks.
“Growth is where it's at right now,” says Hill. “In our old facility we had 7,000 SF and were truly cramped for space.” To
alleviate this problem Hill went before the company’s Board
and explained how, in order to keep growing and to continue
to provide quality services, the company needed more room.
His efforts paid off. “We purchased a building in Midland
- more than double the size of our current facility. It was a
17,000 sf warehouse with just admin areas – an open space.
We gutted the admin areas and built brand new lab areas.”
In addition to the “givens” such as administrative, sales and