Customized Nutritional Solutions For Laboratory Animals

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1 A LT R O M I N Customized Nutritional Solutions For Laboratory Animals Dear Sir or Madam, we would like to thank you for a good and successful co-operation in 2008 and furthermore we wish you and your familiy a merry christmas and a happy new year. Your Altromin-Team Current news NEW LABORATORY FINISHED Production of bench-scaled special diets accordant to FDA/GMP requirements TOTAL-PATHOGEN-FREE DIETS Germ-free diets without autoclaving and irradiation? Our cost-efficient alternative - TFP diets.

2 NEW LABORATORY FINISHED We are pleased to introduce you our new laboratory today. Apart from special and purified diets, we also produce diets mixed with special substances and modified standard diets in bench-scale according to the strict requirements of Good Manufacturing Practice (pharmaceutical GMP). But more than this... Our new production facility allows us to produce batch quantities from 10kg up to 3.000kg. That assures the production of bulked special diets in one batch and contributes considerably to the safety and reliability of the customers' research results. Deficiency and excess diets, vitamin, mineral, trace element diets as well as amino acid and fatty acid diets - an adjustment of any nutritive parameter is possible. Our scientists are always available for questions and consultancy. Please call us! ADVANTAGES OF THE NEW LABORATORY PRODUCTION AT A GLANCE - Modern weighting system based on calibrated precision scales - EDP-related formula and weighting system - logging and verficiation of the used raw materials and components - access security system and audit trail according to FDA requirements - validation according to GAMP/FDA - Various batch mixers, batch quantities from 10kg up to 3.000kg possible - Special mixing tools assure highest mixing accuracy and homogeneity - Varoius pellet sizes, possibl from 2mm up tp 15mm - Prevention of cross-contamination because of plant engineering - Facility is strictly separated from standard production - Quality management accordant to GMP requirements assures optimal production flow

3 PICTURES OF THE LABORATORY MIXING Mixer used for quantities bigger than 150kg. Closed production line with special dedusting unit. All mixers have been qualified and verified accordant to GMP requirements for an accuracy of minimum 1: Mixers with special mixing tools for highest accuracy and homogeneity. These pharma mixers will be used for the production of batch sizes from 10 to 100kg. Product contacted surfaces are made of stainless steel for residue-free cleaning procedures. Two pellet mills for different requirements and capacities. Various dies for pellet sizes between 2mm and 15mm available. Best possible pellet quality using modern production equipment. PRESSING

4 PICTURES OF THE LABORATORY Cooler and dryer with special air-filter. COOLING & DRYING Combined cooling and drying unit for quantities between 10kg and 100kg. Fast drying using flue-curing and a final cooling with HEPA filtered air. It is necessary to assure a fast drying and cooling for optimal microbiological stability. As a result of process enhancement, a residual moisture of <12,5% as well as and end temperature of <35 can be accomplished within 30 minutes - germ content 10 1 to 103 cfu/g GMP compliant storage of raw materials. All raw materials are labeled with barcode, batch no. and expiration date. A mistaken usage of raw materials as well as usage of expired raw materials can be excluded because of the EDP related system. FIFO principle cannot be violated. STORAGE

5 TOTAL PATHOGEN FREE DIETS Breeding and maintenance diet for rats and mice Our scientists and technologists have developed a completely new manufacturing method which effective reduces the microbiological germ status comparable to autoclaved and irradiated diets. TPF is particularly suitable for use in SPF-barriers or areas where an absolutely abacterial status is required. By using a modern double vacuum packaging, the risk of recontamination can be avoided. TPF feed is available as breeding and maintenance diet for rats and mice. ADVANTAGES OF TPF DIETS AT A GLANCE Time and cost savings because of elimination of the autoclaving and irradiating process - No changes in chemical characteristics as an effect of heat Same ingredients, same raw materials as in standard breeding (1314) and maintenance (1324) diets 30% cheaper than irradiated d5ets Safety - TPF diets will be delivered with a batch-related chemical and microbiological analytical report Sterile, double vacuum packaging avoids recontamination Upper PE-foil can be removed and the package can be channeled into the barrier or isolator via e.g. dip tank 12 months minimum durability Lightweight packages à 5kg Standardized breeding and maintenance diets in known Altromin quality

6 TOTAL PATHOGEN FREE DIETS TPF diets will be delivered with a chemical and microbiological analytical report, free of charge. Germ-free, cost-efficient and user-friendly: Breeding diet, 10mm square pellets Maintenance diet, 10mm round pellets Therefore, a mix-up can be excluded. User-friendly 5kg vacuum packages Flexible, lightweight and safe... See for yourself and ask for a product sample. No changeover required! TPF diets for rats and mice - proven and long-time tested Altromin standard formulas. No changes in composition, no changes of ingredients and raw materials......only germ-free...

7 A LT R O M I N FOR ANIMAL HEALTH We're looking forward to a good and innovative co-operation

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