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Importance Of Separating Manufacturing Process For Penicillin And Non-Penicillin

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In 1928 the Scottish scientist Alexander Fleming discovered penicillin, a drug that became the first widely used antibiotic in existence and that still remains one of the most widely used drugs for treating bacterial infections.

Produced by a species of fungi, penicillin is able to kill several species of bacteria due to its molecular structure. It contains a beta-lactam ring, which is a ring of carbon atoms that is able to interrupt the growth of bacteria. This ring is so effective at killing bacteria that there is now a whole family and subfamilies of beta-lactam antibiotics, all based around this same molecular structure.

Examples of Beta Lactam Antibiotics:

  • Cephalosporins – cefaclor, cephalexin
  • Carbacephems – loracarbef
  • Monobactams – aztreonam
  • Penicillins – ampicillin, oxacillin
  • Penems – imipenem, meropenem 

Side Effects of Penicillin:

Although penicillin is a very effective drug, it does have some side effects, with the most important being allergic reactions. About 10% of people will be allergic to penicillin, which can trigger rashes, itchy eyes, and swollen tongue and face. In serious cases, an allergic reaction to penicillin can lead to difficulty breathing and anaphylactic shock, a potentially life threatening result of allergic reactions that can be fatal. 

A simple skin test can be performed to assess whether a person is allergic to penicillin before they are given a full dose of the drug; an increase in a blood chemical called immunoglobulin-E is an indication that the person is allergic to beta-lactam antibiotics such as penicillin. People who have asthma or hay fever may be more likely to be allergic to penicillin. Moreover, if a person is allergic to penicillin, they will also be allergic to nearly all other beta-lactam antibiotics.

Cross Contamination

Current guidelines from the US Food and Drug Association (FDA) are in place that cover the manufacturing processes that pharmaceutical companies must follow. In order to avoid cross contamination of beta lactam and non-beta lactam products, separate manufacturing facilities should be established for each product.

This includes keeping building structures, equipment, utilities and personnel working with beta lactam and non-beta lactam products separate. Because of the potential for contamination through the air, a proper distance should be observed between facilities, and each should have its own heating, ventilation and air conditioning (HVAC) system. The active pharmaceutical ingredients used in the manufacture of beta-lactam and non-beta lactam ingredients must also be kept separate.

The manufacture of cephalosporin drugs does not require its own facility or air handling system as long as equipment is well maintained and kept clean. For non-beta lactam products, a separate facility is not required either, as long as there is no risk of contamination with beta-lactam products. All guidelines and instructions must be following for cleaning and maintenance in order to minimise cross-contamination.

FDA recommendations say that there is always the potential for cross-contamination, however small. Therefore, all non-beta lactam products should be tested for contamination before sale, and it should not be sold if there is any evidence that the product has been contaminated.

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