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Harmonised Pharmacopoeia Compliant to Dehydrated Culture Media EP 10th Edition 1. Sterility Testing Sterility testing is required when developing and manufacturing products for pharmaceutical applications as part of a sterilisation validation process as well as routine testing before release. Manufacturers must provide adequate and reliable sterility test data to ensure their product meets strict safety guidelines. Neogen offers the below media for sterility testing, which have been developed in accordance with the European Pharmacopoeia (EP) compliance guidelines: Fluid Thioglycollate Medium NCM0108 This medium has been designed for the detection of aerobic and anaerobic organisms including Clostridia spp., Pseudomonas spp. and Staphylococci. The medium has a nutritionally rich base to support the growth of a wide range of organisms as well as low oxygen reduction potential to prevent any species that may have a negative effect on the recovery and growth of contaminants. NCM0108 Tryptic Soy Broth (Soybean-Casein Digest Broth) NCM0004 This is a highly nutritious medium for the cultivation of a wide range of microorganisms including Aspergillus spp., Bacillus spp. and Candida spp. This versatile medium promotes growth of both fungi and aerobic bacteria, and can also be used as a pre-enrichment broth for non-sterile products. NCM0004 2. Examination of Non-Sterile Products Not all products which are released to market are required to be sterile. Instead, to guarantee that the product meets safety and quality standards, manufacturers are required to evaluate the microbial content of each product and ensure no organisms of concern are present. Neogen’s media range for the examination of non-sterile products has been developed for detection and enumeration of each organism specified within the HP including: Bile-Tolerant Gram-Negative Bacteria Enterobacteriaceae Enrichment (EE) Broth Mossel NCM0057 This is a selective broth for the enrichment of Enterobacteriaceae. The medium has also been designed to prevent any natural sterilisation that may occur from acid production, ensuring reliable results you can trust. NCM0057 Violet Red Bile Glucose Agar (VRBGA) NCM0022 To be used in conjunction with the above Enterobacteriaceae Enrichment Broth, our selective Violet Red Bile Glucose Agar is used for the isolation and identification of bile-tolerant gram-negative bacteria. NCM0022 For further information please contact our technical representatives on: +44 (0) 161 820 3833 or email: [email protected] Escherichia coli MacConkey Broth NCM0060 Our MacConkey Broth has been designed for the selective enrichment of E. coli and shows a colour change when bile-tolerant, lactose fermenting organisms are detected. NCM0060 MacConkey Agar NCM0017 Following enrichment with MacConkey Broth, our MacConkey Agar allows you to subculture your sample for the isolation and identification of E. coli. NCM0017 Salmonella Rappaport Vassiliadis Salmonella Enrichment Broth NCM0103 This Salmonella enrichment broth is extremely selective and allows for rapid growth of Salmonellae whilst inhibiting non-target organisms. NCM0103 Xylose Lysine Deoxycholate (XLD) Agar NCM0027 Our Xylose Lysine Deoxycholate (XLD) agar allows for the identification and isolation of Salmonella serovars including S. Typhimurium and S. Abony. NCM0027 Staphylococcus aureus Mannitol Salt Agar NCM0078 Following enrichment from a non-selective broth, such as Tryptic Soy Broth, NCM0004. Mannitol Salt Agar isolates and identifies indicative S. aureus from non-sterile products. The agar’s high salt concentration makes it extremely selective for this organism. NCM00078 Pseudomonas aeruginosa Cetrimide Agar NCM0109 Our Cetrimide Agar has been formulated to detect P. aeruginosa following enrichment from a non-selective medium such as NCM0004. The colonies display differently under normal and UV light for easier identification of suspected P. aeruginosa. NCM0109 Clostridia Reinforced Clostridia Medium NCM0102 This broth provides a selective enrichment for the growth of Clostridia spp. The formulation has been carefully designed to promote strong growth of the microorganism from trace amounts within a sample. NCM0102 For further information please contact our technical representatives on: +44 (0) 161 820 3833 or email: [email protected] Columbia Agar NCM0013 Following sample enrichment from our NCM0102 broth, Columbia Agar provides a selective media for the isolation and identification of Clostridia and other fastidious microorganisms that require a nutritious agar base. NCM0013 Candida albicans Sabouraud Dextrose Broth NCM0147 Our Sabourand Dextrose Broth provides a selective base for fungal growth including the enrichment of Candida albicans. Developed with an acidic pH to enhance selectivity, the broth is used prior to NCM0147 plating onto a selective agar. Sabouraud Dextrose Agar NCM0008 Sabouraud Dextrose Agar is the specified medium for the identification of Candida albicans in non-sterile products. The selective, nutritionally rich agar is able to identify and differentiate fungi whilst a low, acidic pH inhibits bacterial growth. NCM0008 3. Cultivation of Microorganisms Often you may be required to prepare bacterial cultures for the protocols specified within the HP. Neogen offer a range of non-selective, nutrient dense broths and agars that have been developed for this purpose. Potato Dextrose Agar NCM0018 Our Potato Dextrose Agar is ideal for the cultivation of fungi, in particular Aspergillus brasiliensis test strains. The natural properties within potato starch and dextrose allow for a rich agar base with nutrients that encourage weaker moulds to grow, as well as the production of high colour NCM0018 pigmentation for easier identification. Tryptic Soy Agar (Soybean-Casein Digest Agar) NCM0002 Tryptic Soy Agar is a non-selective agar suitable for the cultivation of a wide range of microorganisms and is sometimes referred to as Tryptone Soy Agar, or TSA. NCM0156 Buffered Sodium Chloride-Peptone Broth pH 7.0 NCM0156 Our Buffered Sodium Chloride-Peptone Broth has been developed for the resuscitation and growth of bacterial cultures. It can be used both as a medium for sample preparation or as a diluent for microbial testing. Our NCM0004 Tryptic Soy Broth can also be used in the cultivation of microorganisms due to its NCM0156 non-selective properties. For further information please contact our technical representatives on: +44 (0) 161 820 3833 or email: [email protected] What is Harmonised Pharmacopoeia? Harmonised Pharmacopoeia (HP) is a collection of legally binding standards and specifications for the production of medicines. The HP is derived from three regional pharmacopoeias; the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia (USP/EP/JP), with the aim of providing globally interchangeable manufacturing compliance methods. Our HP Media Range Neogen has developed a complete range of dehydrated culture media (DCM) for pharmaceutical applications that is formulation and performance compliant according to the latest EP 10th edition, newly implemented in January 2020. Compliance is demonstrated via our Technical Specification Sheets and Certificates of Analysis. Our range includes media for: Sterility Examination of Cultivation of Testing Non-Sterile Products Microorganisms Our media is ideal for use by those within the pharmaceutical industry who are manufacturing drug, cosmetic, disinfectant or clinical use products, as well as specialist contract laboratories. We also have a range of complementary media, such as R2A Agar, available to support these testing applications. Why Use HP Compliant Media? By ensuring your testing is carried out with media that is formulation and performance compliant according to the latest edition of the harmonised European Pharmacopoeia, you can be confident that your products meet strict quality and safety guidelines. For further information please contact our technical representatives on: +44 (0) 161 820 3833 or email: [email protected] Why Choose Neogen? Neogen specialises in microbiological culture media and develops, manufactures and supplies products from its headquarters in Heywood, UK. Neogen has an international reputation for the quality of its dehydrated culture media. Neogen is certified to ISO 9001:2015 and ISO 13485:2016 for the design, manufacture and supply of microbiological culture media, antibiotic supplements and diagnostic products. HP Order Information Product Code Product NCM0156 Buffered Sodium Chloride-Peptone Broth pH 7.0 NCM0109 Cetrimide Agar NCM0013 Columbia Agar NCM0057 Enterobacteriaceae Enrichment (EE) Broth Mossel NCM0108 Fluid Thioglycollate Medium NCM0017 MacConkey Agar NCM0060 MacConkey Broth NCM0078 Mannitol Salt Agar NCM0018 Potato Dextrose Agar NCM0103 Rappaport Vassiliadis Salmonella Enrichment Broth NCM0102 Reinforced Clostridia Medium NCM0008 Sabouraud Dextrose Agar NCM0147 Sabouraud Dextrose Broth NCM0002 Tryptic Soy Agar (Soybean-Casein Digest Agar) NCM0004 Tryptic Soy Broth (Soybean-Casein Digest Broth) NCM0022 Violet Red Bile Glucose Agar (VRBGA) NCM0027 Xylose Lysine Deoxycholate (XLD) Agar Pack sizes are available in 500g, 5kg, 10kg and 25kg. For more information about our Harmonised Pharmacopoeia product range, or any of our other microbiological media solutions, why not contact us today? Tel: + 44 (0) 161 820 3833 • Fax: + 44 (0) 1292 525 602 Email: [email protected] Web: foodsafety.neogen.com/uk/neogen-culture-media NE8501_0120.
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