Can penems or cefa category be manufactured in Penicillin facilities? All are belongs to beta lactam category only.
Because of the potential health risks associated with cross-reactivity (cross-sensitivity) of betalactams, manufacturers should assess and establish stringent controls (including appropriate
facility design provisions assuring separation) to prevent cross-contamination. Just as FDA
considers the separation of production facilities for penicillins to be current good manufacturing
practice, FDA expects manufacturers to treat sensitizing non-penicillin beta-lactam-based
products similarly.
Specifically, FDA recommends that manufacturers establish appropriate separation and control systems designed to prevent two types of contamination:
(1) the contamination of a non-penicillin beta-lactam by any other non-penicillin beta-lactam, and
(2) the contamination of any other type of product by a non-penicillin beta-lactam.
Accordingly, FDA recommends that the area in which any class of sensitizing beta-lactam is manufactured be separated from areas in which any other products are manufactured, and have an independent air handling system. As with penicillin, the section of a facility dedicated to manufacturing a sensitizing non-penicillin beta-lactam should be isolated (i.e., completely and comprehensively separated) from areas in the facility in which other products are manufactured. This control applies to each of the five classes of sensitizing beta-lactams; the area in which any class of sensitizing beta-lactam is manufactured should be separated from areas in which any other products are manufactured, including any other class of sensitizing beta-lactam. Manufacturing that is restricted to a specific class of beta-lactam compound (e.g., the cephalosporin family of products) generally would not
mandate separate facilities and air handling systems, and could permit production campaigning
and cleaning as sufficient control.
Beta-lactam antibiotics include the following five classes,
• penicillins (e.g., ampicillin, oxacillin)
• cephalosporins (e.g., cephalexin, cefaclor)
• penems (e.g., imipenem, meropenem)
• carbacephems (e.g., loracarbef)
• monobactams (e.g., aztreonam)
Allergic reactions associated with penicillins and non-penicillin beta-lactams range from rashes
to life-threatening anaphylaxis. Immunoglobulin E (IgE) antibodies mediate the immediate
hypersensitivity reactions that are responsible for the symptoms of hay fever, asthma, hives, and
anaphylactic shock. IgE-mediated hypersensitivity reactions are of primary concern because
they may be associated with significant morbidity and mortality. There is evidence that patients
with a history of hypersensitivity to penicillin may also experience IgE-mediated reactions to
other beta-lactams, such as cephalosporins and penems.
All non-penicillin beta-lactams also have the potential to sensitize individuals, and subsequent
exposure to penicillin may result in severe allergic reactions in some patients. Although the
frequency of hypersensitivity reactions due to cross-reactivity between beta-lactam classes can
be lower than the risk within a class, the hazard posed is present and potentially lifethreatening. The potential health hazard of non-penicillin beta-lactams therefore is similar to that of penicillins.