[+] PurifiDE XG, Purified Siliceous Earth USP-NF High Purity Filter Aids for pharmaceutical and related uses

PurifiDE® XG-1 (100 mD), PurifiDE XG-3 (300 mD), and PurifiDE XG-12 (1200 mD) Purified Siliceous Earth USP-NF Filter Aids labeled, "Bulk Pharmaceutical Excipient Filter (BPEFA) can be used as components (21 CFR Part 210.3) in the filtering of human and animal drug products. EP Minerals manufactures PurifiDE® XG Purified Siliceous Earth BPEFAs according to Current Good Manufacturing Practices for Bulk Pharmaceutical Excipients (USP40-NF35 <1078>).

Typical uses include:

• Fractionation of blood plasma proteins at manufacturing scale
• Filtration of active pharmaceutical ingredients (APIs) dissolved in aqueous or organic liquids
• Rapid clarification of cell culture media or cell lysates containing soluble recombinant biopharmaceuticals without centrifugation
• Filtration of salt solutions and buffers, amino acids, and peptides used in pharmaceutical manufacturing

Manufacturing Process

PurifiDE® XG Purified Siliceous Earth USP-NF BPEFAs are produced in the USA from unique low-density DE ores. Following calcination, the DE is further purified using a proprietary cGMP compliant process in a closed manufacturing facility using qualified equipment, validated processes, batch records, and thorough documentation. The strictly controlled manufacturing processes, including in-process QC testing, and final product QC testing. Through EP's manufacturing processes of purified DE, ICH Q3D Class 1, Class 2A, and several Class 3 elemental impurities from the PurifiDE XG-3 and PurifiDE XG-12 are typically reduced to trace levels when using a strongly acidic filtrate in the lab (Table 1).

Quality Control

PurifiDE® XG Purified Siliceous Earth USP-NF BPEFAs are subject to rigorous quality control testing which guarantees that every production lot of PurifiDE® XG meets, or exceeds the standards specified in the USP 40-NF 35 Monograph on Purified Siliceous Earth. Three independent samples from each lot (450 kgs) are tested in EP Minerals' cGMP compliant QC laboratory using qualified analytical instruments and validated or verified compendial and non-compendial tests. Tests listed on the Certificate of Analysis for PurifiDE® XG Purified Siliceous Earth USP-NF BPEFAs are shown in Table 2 A and 2 B. Please contact your EP Minerals Sales Professional to obtain copies of Certificates of Analysis for PurifiDE XG Purified Siliceous Earth USP-NF BPEFAs.

Regulatory Support Documentation

Please request regulatory support documents from your EP Minerals Sales Professional.

Packaging and Labeling

PurifiDE® XG Purified Siliceous Earth USP-NFBulk Pharmaceutical Excipient, Filter Aids are packaged in 55-gallon (208-liter) paper fiber drums, with metal ring reinforced top and bottom, hard plastic covers, and a locking steel band with tamper-evident seals. The drums contain 100 lbs. net of product (45.36 kg) and are lined with food grade plastic bags. Each drum carries a label as shown below, including safety information. Other packaging formats, including bulk-bags, and Tyvek bags are available upon request.

Figure 1. 55-gallon (208-liter) paper fiber drum containing PurifiDE XG-12 USP-NF Purified Siliceous Earth (Bulk Pharmaceutical Excipient Filter Aid GMPs). Top cover is locked in place with a steel band and a tamper-evident seal. Product in the drum is contained in a food-grade plastic bag.