Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1
Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine for making product with differnet environmental controls Variety in packaging systems from dessicant containing effervescent tubes to PET bottles. 2
18/04/2018 IVC Brunel Number one large scale UK VMS supplier Customer partnerships with leading retailers and global blue chip consumer brands. UK development and production capabilities. Global sourcing Award winning technical support. Sector leading quality standards. Winners of the Queen s Award for Enterprise 2015 IVC Brunel Healthcare 3
18/04/2018 If we have compliant raw materials, then we can formulate a product Solid Tablets Chewable Tablets Soft Gel Capsules Hard Capsules Herbal Products Coated and uncoated tablets in a variety of shapes and sizes Wide range of chewable formats in popular flavours Range of pure oils including cod liver oil and fish oil Gelatin & Gelatin Free A wide portfolio including medical licenses and traditional registrations 4
18/04/2018 Legislation It is expected by the consumer and fundamental to good practice that all raw materials and products must: 1. Comply with all current European legislation applicable to food supplements. * 2. Not have been treated with irradiation of any kind nor come into contact with irradiated materials. 3. Not include ingredients that are genetically modified (GM) nor derived from GM organisms. 4. Comply with relevant purity standards where ingredients have an E number under EU food additive regulations. * this includes, but is not limited to the following regulations: Slide 5 5
Regulations and Best practice Good Manufacturing Practices - EEC Guide Volume IV Good Warehousing Practices - PQG Monograph Good Laboratory Practices - EEC Guide Volume IV Food Safety Act 1990 Weights and Measures Act 1985 EC Regulation 258/97 on Novel Foods EC Regulation 1169/2011 on the provision of food information to consumers EC Regulation 1924/2006 on Nutrition and Health Claims EC Directive 89/396/EC Indications or Marks Identifying the Lot to which a Foodstuff Belongs EC Regulation 178/2002/EC General Principles and Requirements of Food Law EC Directive 2002/46 EC Approximation of the Laws of the Member States relating to Food Supplements EC Regulation 1924/2006/EC Nutrition & Health Claims made on Foods EC Regulation 1129/2011 and 1130/2011 for food additives and associated purity criteria 231/2012 EC Regulation 1881/2006/EC Setting Maximum Levels for Certain Contaminants in Foodstuffs (including limits on Heavy Metals in Food Supplements) EC Regulation 396/2005/EC Maximum Residue Levels of Pesticides in or on Food or Feed of Plant and Animal Origin EC Regulation 999/2001/EC Prevention, Control and Eradication of Certain Transmissible Spongiform Encephalopathies EC Regulation 1829/2003 and 1830/2003/EC Genetically Modified Feed and Food EC Directive 1999/2/EC Foods and Food Ingredients Treated with Ionising Radiation EC Regulation 1935/2004/EC Materials and Articles Intended to come into Contact with Food IADSA / EHPM / FSE / CRN Quality Guide Slide 6 6
18/04/2018 Manufacturing standards Every step in the supply chain must be controlled and in accordance with all appropriate standards. With regards our manufacturing site we operate to: Food - HACCP, Safety, Allergen control, BRC Pharma MHRA, FDA, GMP, Positive release of all products Best of both - Stability, efficacy and safety. Compliant to highest standards. 7
Manufacturing Preparation including selection and dispensing batch quantities 8
Granulation 9
Blending Important Validate the process so can be confident every product will achieve an even distribution 10
Manufacturing Tablets A Mixture of particle sizes helps compression 11
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Tablet presses 15
Swallowable tablets Uncoated Film coated - colour or clear Sugar coated What are the advantages and disadvantages of each? Cost Appearance Ingredients 16
Film Coating 17
Sugar Coating White or coloured, odour, ease of swallowing. Cost, time, sugar! 18
Chewables and Melts Fast melt a tablet which dissolves in the mouth in a few seconds Melt = could dissolve in the mouth, but is generally much closer to a chewable. Chewable = Crunchable Limitations Loading a fast melt <10% active Actives bitter tastes Sweeteners limits and preference Stability - hygroscopicity Bases: Sugar Polyols 19
Effervescent tablets Typically about 4.5g in weight, the majority of which is sodium bicarbonate and citric acid. Actives bitter tastes Sweeteners limits and preference Stability - hygroscopicity Must be manufactured and packed in low humidity environment 20
Tablet Testing Weight control, hardness, friability, organoleptic, disintegration, dissolution 21
Manufacturing Capsules 22
Hard shells Slower and more expensive than tablets, also more restricted fill size 23
Soft gels Perfect for oils 24
Tests Moisture content, hardness, seal thickness 25
Conclusion Food supplement manufacture is a complex regulatory area with many overlapping pieces of legislation. Each needs to be carefully considered and interpreted The way materials are chosen and sourced is a key part of a successful product, but so is the way they are manufactured. There are scare stories on the web about methods of manufacture and use of excipients. While we haven t discussed those today, needless to say excipients are essential to production of any kind. The less we use the better, but that is to keep products small and easy to swallow, not because there are any concerns over their use. Slide 26 26