
Syntratech Corporation formulates unique and highly
effective herbal dietary supplements. Our goal
is to provide the finest quality supplements available
anywhere. We are proud to offer Diatroxal®,
made only from the finest pharmaceutical grade
ingredients available with clinical
testing of its affectiveness and efficacy.
Contact Information
Sales:
Toll Free: 1-888-421-0374
International: 1-303-488-3328
Fax: 1-303-805-2361
E-Mail: sales
syntratech.com
Product Questions:
Toll Free: 1-888-421-0374
Email: info
syntratech.com
Customer Service:
Toll Free: 1-888-421-0374
Email: support
syntratech.com
Mailing Address:
Syntratech Corporation
4610 South Ulster Street, Suite 150
Denver, CO 80237
Quality Control
All of our raw materials must pass stringent quality
controls before they are utilized. In addition,
we use only those precursor materials that are
of the highest quality and that pass our in house
quality inspection.
All raw materials are tested for purity prior
to production. Quality control engineers have the
authority during any stage of production to reject
any product that does not adhere to our strict
quality standards. All personnel follow explicit
written protocols that are strictly enforced during
the manufacturing process. All steps during the
manufacturing process are documented and reviewed
by quality control specialists. Manufacturing equipment
is properly maintained and cleaned on a predetermined
schedule that is documented in company logs for
review by the Department of Agriculture and the
Food and Drug Administration. The Department of
Agriculture also has jurisdiction over equipment
and GMP's. This helps to ensure the absence of
any contamination during the manufacturing process.
Production records associated with each unit of
a product, including all raw materials used, are
filed for two years past the expiration date.
Further quality control is demonstrated
by:
Product analysis - This is recorded
for each product that is manufactured. The analysis
contains the specific components of the herbal
product, including a lot number for each of the
ingredients, as well as the production methods
used.
Raw materials - These are purchased
only from reputable wholesalers. Each raw material
in our products must come with a Certificate of
Analysis obtained from the supplier. Our in house
Quality Assurance team also analyzes the raw materials
for authenticity.
Packaging material - All packaging
materials are purchased only from reputable wholesalers.
Specific Quality Assurance personal ensure that
all labels are assigned to the proper products
to avoid any confusion. All new labels are cross
checked with the original master label to make
certain that there have been no mistakes during
the printing process.
Lot Numbers - Once an order request
has been received, the herbal supplement to be
manufactured is entered in the production records
and a lot number is assigned. The raw materials
are released to the pharmacy after all products
have been checked for authenticity.
Syntratech Corporation Manufacturing Guidelines
In addition to the protocols described above,
Syntratech Corporation adheres to the following
manufacturing guidelines to ensure the utmost quality
control:
Blending and Granulation - All
equipment used in the process of mixing and granulation
is inspected by the Director of Operations prior
to use. Raw materials are then inspected for the
final time. The lots are then processed using strict
written guidelines for each herbal product. Following
granulation and blending, the powder blends are
stored in specially designed containers to ensure
freshness and to avoid any contamination. Once
again the Director of Operations ensures that all
new blends are labeled appropriately.
Tabletization and Compression -
Once a test unit has been processed, a sample unit
is issued to Quality Assurance to be compared to
retained samples in order to ensure product integrity.
Once the new unit has been approved by Quality
Assurance, full line production may begin. Quality
Assurance inspections are conducted using set protocols
for the caplets. As with the blending and granulation
process, the caplets are stored in specifically
designed containers to ensure freshness and to
avoid any contamination. The Director of Operations
makes certain that all new capsules are labeled
appropriately.
Packaging and Inspection - Upon
completion of processing, the final product is
inspected again by the Quality Assurance staff.
Broken caplets, and any other defective products
are removed from the lot. Products released by
the Quality Assurance staff are subsequently either
packaged for bulk storage or bottled and labeled
for consumer use (labels contain the appropriate
information required by the Federal and Drug Administration;
batch numbers are logged). All finished products
are properly labeled and closed with a tamper proof
seal. The Quality Assurance unit also retains samples
of raw materials for one year past the expiration
date of the last product they are used in. The
unit also retains samples of finished products
for one year past the product expiration date.
These samples are maintained under controlled conditions.
Final Products - All final products
are stored in quarantine in a climate controlled
environment until final delivery to the customer.
All Syntratech Corporation supplements are manufactured
using Good Manufacturing Practices set forth by
the US Food and Drug Administration. In addition,
both scheduled and surprise inspections by the
Quality Assurance staff during different aspects
of the manufacturing process help to ensure specific
quality, strength and purity for both the raw materials
and the finished supplements.