AmPharmCo Facilities

AmPharmCo occupies approximately 37,000 square feet on a 5 acre site in the Amon Carter Industrial Park in Fort Worth, Texas. The manufacturing facility is comprised of a 5,000 square foot Liquid Processing Area, and a 15,000 square foot warehouse with additional off-site space available. All manufacturing and warehousing areas are supported with air handling systems to control temperature and ventilation. Manufacturing areas are supported with separate HVAC systems for air filtration, proper ventilation, heating and cooling. All components and materials for use in manufacturing are quarantined until released as per CFR 21 Section 211.80, Section 211.82 and Section 211.84.

The facility is equipped with a validated 5-point of Use Reverse Osmosis USP Purified Water System that produces purified water for all manufacturing processes in compliance with current USP requirements. Expansion of the current facility is planned in the near future.

AmPharmCo’s manufacturing capabilities are broad in nature. Liquid process tanks and kettles with several different mixing modes range from 80 gallon Pilot kettles to 3,000 gallon scale-up tanks for manufacturing liquids to lotions, creams and gels. Product batches from 25 to 2000 gallons may be produced. Several vessels are equipped with jackets for temperature control. Accompanying support equipment such as transfer pumps, mills, scales and lifts ensure safe, efficient and reproducible manufacturing. All manufacturing vessels meet FDA requirement as stated in CFR 21 Sections 211.63 and 211.65. Approved batch production records are used for all product manufactured in accordance with CFR 21 Section 211.101 and 211.188.

Cleaning, sanitizing, maintenance and use of manufacturing equipment is documented in written logs in accordance with CFR 21 Section 211.182.

The Packaging area contains equipment, i.e. fillers, cappers, labelers, accumulation tables, cartoners, and conveyors that meet FDA requirements as stated in Section 211.63 and 211.65.Packaging capabilities include a state-of-the-art 2 ounce to 2.5 gallon liquid filler for a wide range of product matrices and viscosities. Solutions to shampoos and creams may be filled, with heat sealing available for gallon fill products. Larger capacity filling from 5 to 55 gallons is available.

After capping, jet coding can be applied to bottom of each container as well as to the label. The labeler has single or two-panel capability. Conveyors carry dozen boxes to an automatic sealer. Filled product is 100% inspected by trained production personnel. Current production rate examples for the liquid line are: 8,000 - 16 ounce containers per 8-hour shift, and 2,000 - gallon containers.

State-of-the-art plastic and metal tube filling equipment capabilities include 7.5 mL to 8 ounce filling capacities with heat seal or folded metal crimp. Current production rates are 3,000/hr for most tube sizes.
Powder manufacture and filling capabilities are planned in the future.

All packaging operations are completed and controlled according to CFR 21 Section 211.130. The cleaning, sanitizing and maintenance of packaging equipment is performed in accordance with CFR 21 Section 211.67, and written logs are maintained as per 211.182.

AmPharmCo’s Quality Control and Microbiology Laboratories are capable of full in-house compendial testing of raw materials, in-process and finished products in accordance with CFR 21 Section 211.84, Section 211.160 and Section 211.165. Quality Control capabilities include complete testing throughout each stage of the manufacturing process, using meaningful stability indicating methodology. Instrumentation used for all testing is qualified according to cGMP guidelines. High Performance Liquid Chromatography (HPLC) is the primary mode of analysis for product actives and preservatives.

Agilent Technologies series 1050 HPLC systems equipped with diode array or variable wavelength detection, autosamplers and Chemstation analytical software assure reliable results. Other techniques used for analysis are Gas Chromatography, UV-Vis Spectrophotometry, Fourier Transform Infrared Spectrometry (FT-IR), pH, Refractive Index plus Colorimetric, Titrimetric, Gravametric, Rheometric and wet chemical methods.

All records and reports of analysis are maintained as per CFR 21 Section 211.180.