copyright 2019, Schaefer Technologies Inc - capsule filling machine division.

 

Schaefer Technologies
4901 W. Raymond Street
Indianapolis, Indiana 46241
Phone: (317) 241-9444
Toll Free: (800) 435-7174
Fax: (317) 240-1273

 
 
 
 
 
 
Capsule filling machine manufacturer.
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 Nutraceutical and cGMP Compliance in Manufacturing
 
      The dietary supplement and nutraceutical market is changing rapidly in response to the FDA's new Dietary Supplement Current Good
Manufacturing Practices (cGMPS) "Final Rule" (21 CFR Part 111), published on June 25, 2007. The Final Rule adopts all requirements
specified in 21 CFR 210 and 211, which affect pharmaceutical manufacturers, and apply to all companies that manufacture, package, label,
or hold dietary supplements and nutraceuticals. Dietary supplements or nutraceuticals imported from outside the United States are also
subject to the Final Rule.
 
Schaefer Technologies, Inc. is a leading machine manufacturer of capsule filling, capsule banding and capsule polishing  equipment
with a long and successful history of manufacturing and delivering quality CGMP compliant equipment and products to the pharmaceutical
and nutraceutical (natural foods) industries. Manufacturing and exporting quality automatic and semi-automatic capsule filling and banding
machines for pellets, tablets, powder, and liquids. We also manufacture capsule inspection and capsule polishing machines.
Products are supplied worldwide and we offer custom designs and OEM services which are always welcomed. Shown
below are the STI Model LF-10 and the STI Model 10 ver 4.2. Both are cGMP Compliant capsule filling machines.
 
Capsule fill, oil and paste machine (shown). STI Model10 ver4 Semi-Automatic Capsule Filling Machine for Powder and Beads      

STI Model LF-10

STI CB-15

STI Model 10 ver.4.2

for Liquid and Paste

Capsule Bander

for Powder and Pellets
         
     
      According to the FDA, cGMPs are intended to establish a comprehensive system of process controls, including documenting each
stage of the manufacturing process, to help minimize or detect problems like contamination early in the manufacturing process. The process
controls that are part of cGMPs 210 and 211 are essential to ensure that dietary supplements or nutraceuticals are manufactured, packaged,
held, and labeled in a consistent and reproducible manner. The Final Rule was also implemented to align with current ICH guidelines
including - Q2r1, Q7, Q8, Q9, and Q10. These documents, published by the International Conference on Harmonization, establish best
practices for instrument and analytical procedure validation, as well as implementing a robust quality system.
 
Compliance Dates:
The dates for dietary supplement and nutraceutical companies to be in compliance with the Final Rule are based on number of employees:
June 25, 2010: Fewer than 20 employees
June 25, 2009: Fewer than 500 but more than 20 employees
June 25, 2008: 500 or more employees
Companies found to be out of compliance could be subject to 483s, warning letters, or non-approvable letters indicating a regulatory
deviation.
 
     The ruling affects any company that manufactures or sells dietary supplements, nutraceuticals, and over the counter (OTC) products
intended to be used by the public. CGMPS are bringing a new level of quality and accountability to the nutraceutical industry.  Those
companies who have specialized in low cost production without making adequate investments in quality systems and personnel training
will be at a disadvantage. For many companies it will be too little, too late. For others it will be the beginning of a 'golden-age' of stability
and growth.
 
Article: GMP in nutraceuticals manufacturing
 
ISPE (International Society for Pharmaceutical Engineering) and cGMP
 
Contract Manufacturing Guidelines:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf

Manufactured to meet Federal GMPs for Dietary Supplements and pharmaceutical-biotech cGMP

 
 
 

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Schaefer Technologies, Inc.
4901 W. Raymond Street
Indianapolis, Indiana 46241
Phone: (317) 241-9444
Toll Free: (800) 435-7174
Fax: (317) 240-1273

copyright 2019 Schaefer Technologies Inc. All Rights reserved. Keywords and compactors