Here is some information regarding what FDA thinks about contamination of penicillian (obtained from their website): * i5 - March 99 HUMAN DRUG CGMP NOTES, ASCII Edition Attached Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non- penicillin solid dosage forms provided there is no further penicillin production in the renovated facility? Reference: 21 CFR 211.42(d), Design and construction features; 211.46(d), Ventilation, air filtration, air heating and cooling; 211.176, Penicillin contamination; FDA By-Lines #3, Nov.77, Procedures for the Detection of Residual Penicillins in Drugs; 21 CFR 436.104 Penicillin Activity; and FDA Guide to Inspections of Validation of Cleaning Processes, July 1993. Yes. However, the decontamination process is extremely difficult and we are unaware of any firm that has successfully decontaminated a penicillin facility and converted it to production of non-penicillin products. Note that at section 211.176 the CGMP regulations require that if a reasonable possibility exists that a non- penicillin drug product has been exposed to cross- contamination with penicillin, the non-penicillin product must be tested for the presence of penicillin and not marketed if detectable levels are found using the codified method. Such a reasonable possibility may be present where decontamination has not been conducted effectively. That would put the responsible firm in a position of having to test each and every lot of non- penicllin product for the presence of penicillin. In sum, while the CGMP regulations would not prohibit decontamination and conversion, the difficulty of cleaning up penicillin residues makes the chore daunting. Contact for further info: Edwin Melendez, HFD-322, 301- 594-0095; e-mail; [log in to unmask] <mailto:[log in to unmask]> Is there an acceptable level of penicillin residue in non- penicillin drug products? Reference: 21 CFR 211.176, Penicillin contamination; 21 CFR 436.104 Penicillin Activity; FDA By-Lines No.3, Nov.77, A Review of Procedures for the Detection of Residual Penicillins in Drugs. Any detectable levels of penicillin residue are considered violative because 21 CFR 211.176 indicates that a non-penicillin drug product must not be marketed if detectable levels of penicillin are found when tested according to procedures specified in The Procedures for Detecting and Measuring Penicillin Contamination in Drugs. The current analytical standard for demonstrating adequate decontamination of facilities, separation within the same building, or measurement of cross-contamination is codified at 21 CFR 211.176 and 436.104 and has a limit of detectability of 0.006 ppm (as Penicillin G using S. Lutea) and a violative detection amount of 0.03 ppm. Note that the latter amount reflects the method's limits with respect to confidence and reproducibility and does not represent a tolerance level. This analytical methodology is limited to the detection of Penicillin G and ampicillin in a limited number of products listed in the referenced method, not including other beta-lactam antibiotics. In situations where this methodology is not workable, it is the firm's responsibility to develop, validate, and use other methodology with similar sensitivity. Contact for further info: Edwin Melendez, HFD-322, 301- 594-0095; e-mail: [log in to unmask]; Dr. Richard Adams, HFD-643, 301-827-5849; e-mail: [log in to unmask] I am aware that there must be separate HVAC systems in-place to prevent the transmission of penicillin and like compounds throughout a facility. Without more detail as to the nature of the situation you are addressing, I am uncertain how to further advise you. Joel C. Harder American Red Cross Quality Assurance Associate for Process Equipment Validation * v-mail: 703-351-5942 * e-mail: [log in to unmask] -----Original Message----- From: Sherry Oxford [mailto:[log in to unmask]] Sent: Thursday, September 30, 1999 3:38 PM To: [log in to unmask]; [log in to unmask] Subject: [PMFLIST] Penicillin Contamination Hi everyone! Does anyone have experience with or know of good references concerning penicillin (and other similar antibiotics) contamination within the laboratory (chemistry and micro)? How much of a problem is this? I have some knowledge of penicillin contamination within a manufacturing setting (special handling, etc.etc.), but did not know of these types of compounds being a serious issue within the laboratory if normal handling procedures are employed. Any help or comments would be greatly appreciated! Sherry Oxford UDL Laboratories, Inc. ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community. ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community.