Claims for Patent: 8,084,247

Summary for Patent: 8,084,247

Title:	Biological indicator
Abstract:	A biological indicator for monitoring the effectiveness of a sterilizing or disinfecting treatment or process. A compound or condition is disclosed which comprises a substrate having a surface layer containing functional groups thereon desirably free of silicon linking groups. The functional groups are desirably in the form of a monolayer of a uniformed distribution and of a selected quantity. Various types of microorganism indicators, such as spores, and/or etiological agent indicators are covalently bonded to the surface layer functional groups through a crosslinking reagent and thus form a uniform number and distribution of the microorganism and/or etiological agent indicators. After being subjected to sterilization or other similar disinfecting treatments or processes, along with various articles such as instruments, the indicator can be cultivated to determine the effectiveness of the sterilization, disinfection, etc. treatment or process.
Inventor(s):	Cregger; Tricia A. (Fairlawn, OH), Franciskovich; Phillip P. (Concord, OH), Duda; Mark J. (Twinsburg, OH), Bellow, Jr.; Robert E. (Madison, OH)
Assignee:	American Sterilizer Company (Mentor, OH)
Application Number:	12/658,214
Patent Claims:	1. A biological indicator for monitoring sterility, comprising: a substrate; a plurality of functional groups residing on an exposed surface of said substrate, said functional groups containing about 10% or less of any silicon linking atoms, based upon the total amount of said functional groups; a plurality of microorganism indicators comprising an endospore, a fungi, a mycobacteria, a vegetative bacteria, a protozoa, or any combination thereof; a photoreactive crosslinking agent having one functional end group covalently bonded to one of said surface functional groups and having another functional end group covalently bonded to one of said microorganism indicators, so that a terminal and exposed microorganism indicator is present that is covalently bonded through said crosslinking agent to said substrate, said substrate having a plurality of said terminal and exposed microorganisms bound thereto that are capable of being sterilized by a sterilizing medium, wherein said plurality of said exposed and bound microorganisms covalently bonded through said crosslinking agent to the surface of said substrate have a uniform distribution, wherein the standard deviation of the distribution is about 50% or less based on one unit area of said surface as compared to another unit area of said surface, and wherein the photoreactive crosslinking agent comprises N-Succinimidyl-6-[4'-azido-2'-nitrophenylamino]hexanoate (SANPAH). 2. A biological indicator for monitoring sterility according to claim 1, wherein the amount of said silicon linking atoms is about 5% or less of the total amount of said functional groups residing on the surface of said substrate. 3. A biological indicator for monitoring sterility according to claim 2, wherein said functional groups comprise a hydroxyl, an amine, a carboxylic acid, a carbonyl, an alkene having from 2 to about 20 carbon atoms, a halide, or any combination thereof; wherein said endospore comprises Geobacillus stearothermophilus, Bacillus subtilis, Bacillus subtilis globigii, Clostridium sporogenes, Bacillus cereus, Bacillus circulans, or any combination thereof; wherein said fungi comprises Aspergillus niger, Candida albicans, Trichophyton mentagrophytes, Wangiella dermatitis, or any combination thereof; wherein said mycobacteria comprises Mycobacterium chelonae, Mycobacterium gordonae, Mycobacterium smegmatis, Mycobacterium terrae, or combinations thereof; wherein said vegetative bacteria comprises Aeromonas hydrophila, Enterococcus faecalis, Streptococcus faecalis, Enterococcus facecium, Streptococcus pyrogenes, Escherichia coli, Klebsiella (pneumoniae), Legionella pneumophila, Methylobacterium, Pseudomonas aeruginosa, Salmonella choleraesuis, Helicobacter pylori, Staphylococcus aureus, Staphylococcus epidermidis, Stenotrophomonas maltophilia, or any combination thereof; and wherein said protozoa comprises Giardia lamblia, Cryptosporidium parvum, or any combination thereof. 4. A biological indicator for monitoring sterility according to claim 3, wherein the amount of said silicon linking atoms is less than about 3%; wherein said endospore comprises Clostridium sporogenes, Geobacillus stearothermophilus, Bacillus subtilis, Bacillus subtilis globigii, or any combination thereof; wherein said mycobacteria comprises Mycobacterium chelonae, Mycobacterium gordonae, Mycobacterium smegmantis, Mycobacterium terrae, or any combination thereof; and wherein said vegetative bacteria comprises Streptococcus faecalis, Streptococcus pyrogenes, Escherichia coli, Legionella pneumophila, Pseudomonas aeruginosa, Salmonella choleraesuis, Staphylococcus aureus, or any combination thereof. 5. A biological indicator for monitoring sterility according to claim 4, wherein said functional groups comprise an amine, a hydroxyl, or a combination thereof; wherein said endospore is Geobacillus stearothermophilus, Bacillus subtilis globigii, Bacillus subtilis, or any combination thereof; wherein the amount of silicon linking atoms is less than about 2%; and wherein said standard deviation is about 25% or less. 6. A biological indicator for monitoring sterility, comprising: a substrate and optionally an additional layer residing on said substrate, said substrate or said optional additional layer when utilized having functional groups disposed thereon, said functional groups containing about 10% or less of any silicon linking atoms, based upon the total amount of said substrate or said optional layer functional groups; a plurality of etiological agent indicators comprising a bioterrorism agent, a clinically relevant disease-causing microorganism, a resistant strain of bacteria, a subcellular constituent, or any combination thereof; and a photoreactive crosslinking agent having one functional end group covalently bonded to one of said substrate functional groups or to one of said optional layer functional groups and having another functional end group covalently bonded to one of said etiological agent indicators, so that a terminal and exposed etiological agent indicator is present that is covalently bonded through said crosslinking agent to said substrate or to said optional layer, said substrate or said optional layer having a plurality of said terminal and exposed etiological agents bound thereto that are capable of being sterilized by a sterilizing medium, wherein said plurality of said exposed and bound etiological agent indicators covalently bonded to said substrate or to said optional layer have a uniform distribution, wherein the standard deviation of the distribution is about 50% or less based on one unit area of said substrate or said optional layer as compared to another unit area of said substrate or said optional layer, and wherein the photoreactive crosslinking agent is N-Succinimidyl-6-[4'-azido-2'-nitrophenylamino]hexanoate (SANPAH). 7. A biological indicator for monitoring sterility according to claim 6, wherein said substrate or said optional layer functional groups comprise a hydroxyl, an amine, a carboxylic acid, a carbonyl, an alkene having from 2 to about 20 carbon atoms, a halide, or any combination thereof; wherein the amount of said silicon linking atoms is about 5% or less of the total amount of said substrate or said optional layer functional groups; wherein said etiological agent indicator comprises vancomycin resistant Enterococci (VRE), methicillin resistant Staphylococcus aureus (MRSA), Mycobacterium cheloni, viruses, proteinaceous prions, Bacillus anthracis (anthrax), Clostridium botulinum toxin (botulisum), Brucella spp. (brucellosis), Burkholderia mallei (glanders), Burkholderia pseudomallei (melloidosis), Chlamydia psittaci (psittacosis), Vibrio cholerae (cholera), Clostridium perfringens (Epsilon toxin), Coxiella burnetii (Q fever), nipah virus, hantavirus, food safety threats (Escherichia coli O157:H7, Salmonella spp.), Francisella tularensis (tularemia), Yersinia pestis (plague), Ricinus communis (ricin toxin), Rickettsia prowazekii (typhus fever), Salmonella typhi (typhoid fever), Shigella spp. (shigellosis), Variola major (smallpox), Staphylococcal enterotoxin B, alphaviruses (Venezuelan equine encephalitis, Eastern equine encephalitis, Western equine encephalitis), filoviruses (Ebola, Marburg), arenaviruses (Lassa, Machupo), water safety threats (Cryptosporidium parvum), or any combination thereof. 8. A biological indicator for monitoring sterility according to claim 7, wherein said optional additional layer is not present; wherein said substrate functional group is an amine, a hydroxyl, or a combination thereof; wherein said etiological agent is anthrax; wherein the amount of said silicon linking atoms is less than about 2%, wherein said standard deviation is about 25% or less, and wherein the photoreactive crosslinkinq agent comprises N-Succinimidyl-6-[4'-azido-2'-nitrophenylamino]hexanoate (SANPAH).

Details for Patent 8,084,247

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	11/12/1998		2025-05-24