In the 1967 film
“The Graduate,” Mr. McGuire offers one word of advice to Dustin Hoffman’s
character, Benjamin Braddock – “Plastics.”
A prophetic
statement indeed. Since then plastics have found their way into every corner of
our modern lifestyle. From the packaging our foods and beverages come in to the
vehicles we drive, plastics are everywhere, and we have come to take their
benefits and convenience for granted.
Slow to adapt to
the benefits of plastics is the pharmaceutical industry. Reluctant to change
and heavily invested in stainless steel, it is only recently that the industry
has begun to see the benefits of using plastics in the form of single-use and
disposable equipment.
However, recent
reports of problems with plastic products containing Bisphenol A, commonly
abbreviated as BPA, has put the use of plastics that are in contact with
products consumed by people under the microscope.
The main issues
of concern for pharma and biopharma companies that are using disposables are
leachables and extractables. Extractables are defined as compounds that can
migrate from a material into a solvent under exaggerated conditions of time and
temperature, whereas leachables are compounds that actually do migrate into a
drug product formulation under normal processing conditions.
It’s important that end-users exercise due diligence when selecting equipment with disposable/single-use product contact parts such as this bioreactor line. While many vendors offer extractable and leachable reports for their equipment, end-users have to make sure that their product has no reaction with the disposable equipment. (Photo courtesy: Finesse Solutions)
To find out more
about the use of disposables and the current emphasis on extractable and
leachables, Pharmaceutical Processing spoke to experts at several companies
that supply disposable/single-use products to the industry for their views on
the issue.
The Big Push For Information
“People are
worried about extractables and leachables,” says George Moyer of Broadley-James
(www.broadleyjames.com). “There has been a huge void of information on
extractables and leachables; but in the last 12 – 24 months vendors have become
more adept at providing turnover packages to end-users and they (turnover
packages) have become very comprehensive.”
Moyer states
that early adopters of disposable technologies have forced vendors to provide
full disclosure of all extractable and leachable data. But, he adds, “The
end-user has the responsibility to make sure the products are appropriate for
their use. They must perform due diligence. The end-user has the responsibility
to demonstrate that the product has no reaction with the disposable equipment.”
“We are
absolutely seeing a big interest in extractables and leachables,” says Marcia
Coulson of Eldon James (www.eldonjames.com). “The use of disposables is on a
sharp rise,” she continues. Coulson says companies are looking for products
that are non-animal derived and don’t have oils or plasticizers.
“Everyone wants
to be ‘clean and green’,” she says. In particular companies are very
concerned about the release of harmful toxins when disposable products are
incinerated.
Laura
Okhio-Seaman at Sartorius Stedim Biotech (www.sartorius-stedim.com) says that
when disposables were first implemented in the industry there was very little
interest in extractables and leachables, but now it’s the big “rage”
“Companies are more aware of product and process interaction now and were
not really aware of it before,” she says.
Okhio-Seaman
adds, “There are more aggressive products being produced now. Testing for
extractables and leachables is very important for products such as injectables;
companies have to account for toxicity.” Companies have to take into account
things such as stabilizers and adhesives says Okhio-Seaman. “Something as
simple as a label on a bag can cause problems.”
Arkema’s
(www.arkema.com) Bill Hartzel says extractables and leachables are still a big
concern to end users. “Every product has extractables” says Hartzel, “even
stainless steel.” Hartzel says that since stainless steel has been around for a
long time, processors know what’s coming out. “In many cases these new
materials present an unknown, you must due an extractable/leachable profile to
know what you are dealing with.”
All bag contact parts in this single-use bioreactor are Class VI tested. (Photo courtesy: Broadley James Corporation)
“Extractables
and leachables are manageable issues.” Says Barbara Paldus of Finesse
(www.finesse.com). “It is imperative to select materials known to not have
leachable or toxicity problems,” she adds. “If you have a product that requires
a new type of material, this material must be tested, which is a fairly routine
process. Expensive? Yes. Time consuming? Yes. But once that product is proven,
certified and documented, QA/QC can sign off on it.”
John Boehm,
Colder Products, (www.colder.com) agrees with his colleagues. “There has been a
‘big scare’ recently in regards to leachables and extractables,” he says. “As
recently as five years ago end users didn’t know the difference between
leachables and extractables, or what to ask for when selecting products.” End users
now have a better understanding of the issues says Boehm. “Major industry
suppliers do extractable profiles on their materials, but it is up to the end
user to decide what products work best with the products they are processing.”