PMI® Quality And Research Programs 
For LabDiet® Products

As the leader in the laboratory animal feed business, PMI® is pledged to maintain sound Quality Assurance and innovative research programs.  PMI has the most thorough and rigorous Quality Assurance program in the feed industry.  PMI® manufactures the most nutritionally consistent laboratory nutrition products available.  The following is a summary of our Quality Assurance programs, provided for your information so that you are as comfortable using our feeds as we are supplying them.

the leader in the laboratory animal feed business

PMI® QUALITY PROGRAMS FOR LABDIET® PRODUCTS

TRADITION                                                                                                                     

PMI® LabDiet® products have been the most popular choice of researchers for good reason.  Virtually unchanged since their introduction, PMI®'s basic LabDiet® formulas have been used by researchers worldwide for over fifty years.  Based on the results of extensive ingredient research, controlled refinements are sometimes made to product formulations to compensate for the proven variability in all natural ingredient nutritional content.  We are proud to state that the nutritional composition of our diet has remained the most reliable and consistent on the market.  PMI® provides the most consistently controlled nutrition program used in laboratory animal research.

RESEARCH                                                                                                                      

LabDiet® Research continues to actively investigate new developments and improvements in lab animal science.  LabDiet® people have a storied history of collaboration with the research community.  This effort has resulted in advances made in the compliment of research animals and breeds used, as well as the use of new toxicological or biomedical techniques.  In addition, our research team stays on the cutting edge of nutritional science to improve the understanding of animal nutritional needs and to better define natural ingredient selection.  We invest more in nutrition research than many other feed manufacturers and employ the information gained from our research to enhance our product line.

We believe animals diets that are fed to models used in biomedical research need to be based on sound scientific data.

Through such research, PMI® develops a "Nutritional Standard" for each of the LabDiet® products.  The Nutritional Standard establishes requirements for the:

The Nutritional Standard is the heart of the product and contains the secrets of why and how the product performs.

PMI® has produced the most exacting Near Infrared Reflectance (NIR) feed ingredient calibration in the animal feed industry.  Again setting the industry standard, PMI® has developed these industry-wide calibrations for use in testing both ingredients and finished products.  This broad base of company-wide samples provides a robust database used to produce exacting diets.  Our Quality Assurance program preserves the accuracy and precision of our calibration.

FORMULATION                                                                                                            

In harmony with our Ph.D. Nutritionists, PMI®'s Formulation Department manages the Nutritional Standard requirements for each of the LabDiet® products.  Through computer assisted technology, our experts evaluate and assure all products conform to their Nutritional Standard requirements on a daily basis.

Our LabDiet® Nutrition Standard assures CONSTANT NUTRITION™ formulation.  LabDiet® formulation does not change with individual ingredient price -- there is no interchange between ingredients, such as gluten meal, soybean meal, fish meal, meat meal, etcetera.  Miniscule formula changes are made only when required due to proven ingredient variability of individual ingredient nutritional content.  To minimize the need for such changes, LabDiet products are formulated with a wide variety of ingredients to assure nutrient consistency.

LabDiet® macro and micro formulas are issued by Staff Nutritionists at PMI®'s St. Louis headquarters.  The Richmond, Indiana plant does not change formulas or make substitutions.  PMI®'s Formulation Department provides written instructions for formulas on a daily basis.  Ingredient information collected by daily sampling and testing is automatically fed into our computer matrix via Near Infrared Reflectance (NIR).  The formulas are then updated daily for evaluation to maintain nutritional consistency.

CONSTANT NUTRITION™

A concept and program in diet formulation, exclusive to PMI® LabDiet®, of delivering a constant level of nutrients while taking into account the biological variation of natural feed stuffs.  Ingredients are assayed daily and necessary formulation refinements are made to assure a constant level of nutrient delivery.  The actual set of ingredients used in a diet does not change.

The benefit to the science community is a constant baseline of nutrition to help control unwanted, nutritionally induced variables.  In addition, the constant set of ingredients are assayed for interfering environmental contaminants to further reduce the possibility of unwanted variables introduced through the diet.  An unwanted variable may lead to confounding experimental results.

CONSTANT NUTRITION™ removes uncertainty and assures control, predictability and maintenance of baseline data in research experimentation.

HOUSEKEEPING AND SANITATION                                                                                  

The LabDiet® product line is manufactured exclusively at our drug free, ISO 9001:2000, Richmond, Indiana facility.  No antibiotics, synthetic estrogen, or other such chemicals enter the facility.  Only FDA and AAFCO approved feed additives for feed nutritional uses are permitted in the facility.  Our written housekeeping and sanitation program dictates that we use an outside certified pest control service for advice on rodent control, fumigation, and pest service.  Chemicals used for such purposes are carefully handled in accordance with EPA approved label uses, and no such chemicals are allowed in the feed production area.  Our Quality Assurance Department follows a monitoring program to assure compliance.  Experts and customers have stated that Richmond's pest control program is the best in the animal feed industry.

INGREDIENTS                                                                                                                 

Each ingredient used in the manufacturing of LabDiet® products has a specification sheet issued by PMI®'s Regulatory Department.  Specifications are developed in accordance with the product Nutritional Standard and provide a detailed description of required physical and chemical properties.  PMI®'s ingredient buyers follow these specifications for ingredient procurement.

Before we accept and unload shipments, all ingredients are sampled in accordance with a mandated sampling procedure to guarantee conformance with the ingredient specification.  Ingredients for Certified products are segregated and quarantined from use until tested for a variety of potential contaminates.

Suppliers - Ingredients are contracted with, and accepted only from suppliers that meet or exceed a pre-established list of criteria.  Before approval, each supplier is thoroughly checked out via complete analysis of the ingredient and a review of the supplier's history, and then monitored for ongoing acceptance.  Each shipment of an ingredient is tested in accordance with its specification sheet prior to unloading.  Ingredients are monitored and tested for other nutritional factors on a predetermined basis by our Regulatory Department.  We reject any unsatisfactory shipments.  If the supplier does not continue to measure up to our standard, we remove them from our approved list.

Monitoring Process - Testing of incoming ingredients prior to unloading varies depending upon the ingredient and its intended use.  All ingredients are checked for conformance to visual standard and contaminates, along with texture and odor.  Most ingredients are checked for protein, moisture, and other nutritional factors (ADF, NDF, etcetera) using NIR technology.  Grains (corn and wheat) are routinely checked for mycotoxins such as aflatoxin and vomitoxin.  NIR enables us to look for quality factors in fat and to determine the grades of animal origin ingredients.

MICRO OPERATIONS                                                                                                       

"Micro" refers to the ingredient name for hand mixed vitamins and minerals that are included in all LabDiet® formulations.  Precise calculations are used, and extreme precautions are taken in the creation of micro formulation additives.  Strict procedures are followed for weighing and check-weighing micro ingredients to assure their inclusion at proper amounts.  Critical vitamins (vitamin C and vitamin D) are inventoried daily to assure theoretical versus actual usage (as would be for drugs by FDA current GMPs - 21CFR211).  Storage, handling, and micro addition procedures assure that vitamins and minerals remain stabile.

Micros are hand-weighed and check-weighed on our scales, sensitive to 1/100 of a pound, which are checked regularly for accuracy.  Variances in check-weights are fully investigated and the micro withheld from production until accuracy is verified.  Micros are identified by unique numbers that are part of the manufacturing record to assure proper addition and mixing into the macro mix.

MIXING OPERATIONS                                                                                             

Advance planning is used in determining the daily production schedule.  Product mixing is sequenced, and equipment is flushed prior to production to minimize inter-product mixing, especially when the presence of a product would upset the nutritional balance of another diet.  Our mixer operators strictly follow written sequencing instructions.  Mixing times, including the time of micro addition, are controlled automatically to assure the appropriate mix of all feed ingredients.  Ingredient over-pulls and under-pulls are documented to assure the correct addition of all ingredients.  Micro addition is documented by cross referencing batch numbers to assure proper addition.  Mixing equipment, screws, gates, hoppers, and conveyers are checked for appropriate tolerances and functioning.  Liquid addition is checked for pattern and cut-off, and the batch-by-batch variance is computed and noted on the batch record.

Mixers and metering devices are checked on an ongoing basis for accuracy.  Our procedures assure products contain the right ingredients at the right levels, and minimize cross contamination opportunities.

PELLETING AND EXTRUSION OPERATIONS                                                                   

The large percentage of LabDiet® products are manufactured using either pelleting or extrusion.  Most rodent, rabbit, guinea pig, mini-swine and poultry diets are pelleted.  Most canine, primate and feline products are extruded.  A log maintained during pelleting or extrusion provides vital information about the criteria elements of the process, which are compared to the expected range for the product.  Product specific testing, such as durability, pellet or biscuit size, hardness, and density, is completed.  Coolers are checked for levels, distribution, and temperatures.  Again, sequencing and flushing schedules are followed to minimize the possibility of inter-product mixing.

FINISHED PRODUCT PACKAGING                                                                                  

Our Quality Assurance Department carefully examines packing and other labeling for cleanliness and correctness prior to issuance to production.  The first few bags from each new manufacturing run are removed to thoroughly check for the presence of any foreign matter and to assure the product is in compliance with strict physical standards.  This process is continued until the packer is comfortable that the product is free from foreign product and meets specifications.  Throughout the packing process, the product is checked by the packer to assure compliance with its visual physical product standard.  Representative samples are taken to our Quality Assurance lab for required laboratory testing prior to release of the product for shipment.  At the completion of packing, a variance of actual bag yield is calculated.  If the variance is greater than tolerated by standard, the run is held and an investigation is initiated, regardless of the other quality checks.

QUALITY ASSURANCE                                                                                                  

Our Quality Assurance Department monitors all manufacturing operations to assure compliance with the established procedures, from ingredient receipt through warehousing.  Production operators are responsible for the quality aspects of their particular job function and our Quality Assurance Department continuously trains and monitors their efforts.

Our Richmond laboratory is supplied with the necessary equipment for some testing:

Samples of all Certified products are maintained in a freezer for future reference, if needed.  Samples of other laboratory products are maintained as need dictates.

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