FEATURED ARTICLES

  • How To Use DMF Content To Support Your Application To The FDA

    A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?

WHITE PAPERS & CASE STUDIES

  • Product Development For An Oral Solid Dosage Using Continuous Manufacturing

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

  • Pediatric Dosage Form Considerations For Highly Potent Compounds

    The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. This white paper describes special considerations for selecting appropriate pediatric dosage forms and the benefits of choosing mini-tablets (e.g., orodispensible) for pediatric formulation, particularly for highly potent compounds.

  • Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms

    Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.

  • Identifying Abrasive Wear Risks In Tableting Tooling For Nutraceutical Products

    Tablet presses are used to manufacture a variety of products, such as pharmaceuticals, nutraceuticals, veterinarian products, confectionary, and industrial tablets. Each industry faces unique challenges due to the properties inherent to any particular formulation. A variety of steel types/coatings, tool design modifications/options, and tablet design recommendations can work together to increase tool life and improve tablet quality.

  • Overcoming Encapsulation Issues Caused By Sticky Formulations

    This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation.

  • Considerations When Cleaning Your Tablet Presses & Tablet Tooling

    Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Dirty tools cause tableting and product quality-related problems, such as sticking & picking. Keeping tools clean also decreases premature tool, turret and cam wear, and reduces the risk of product cross-contamination. While most cleaning methods can achieve similar results, utilizing an automated cleaning system, such as an ultrasonic wash with rinse and dryer, can ensure tooling is properly cleaned and dried consistently with limited handling and potential for damage. A warm air-drying process is ideal for preventing moisture and corrosion by pushing warm air through areas, such as key slots, punch cups, and die bores, that may not be dried properly with a traditional towel or cloth.

PRODUCTS & SERVICES

Used Manesty rotary tablet press, model Mark IV, 49 station D tooled, keyed upper punch guides, 1 ton pre compression, 10 ton main compression, 1" max tablet diameter, 13/16" max depth of fill, with change parts for single layer and bi layer tablets, rated 392,196 tablet/hour single layer, 196,098 tablets/hour bi layer, refurbished by IPR in 2014, serial# TPAC2014-072.

Used Kikusui Tablet Press rebuilt by Natoli, Model Gemini 67, 55 station turret, 460 volt, rebuilt in 2008, serial# 1-5577, with (2) Kramer deduster / Lock metal check units.

Factory Demo IMA Prexima 300 rotary tablet press, 33 station, TSM B tooled, 100kn pre compression and main compression, with force feeder, 16 mm max tablet diameter, with 8, 12, 16 and 19 mm fill cams, nominally rated up to 237,600 tph with HMI. Please see attached IMA Prexima 300 tablet press, serial#KC1034 quotation with applicable IMA terms and conditions.

Bora Pharmaceutical Laboratories is a certified drug product manufacturer by Taiwan FDA, U.S. FDA and MHRA which complies with the PIC/S GMP and GDP for drug products, and the authorized operations for manufacturing and packaging non-sterile products for solid dosage form including film-coated tablet (tablets, granules, powder) and capsules.

Fareva offers a one stop shop opportunity for your oral solid dosage, high potent OSD, and sterile injectable needs.

AIM™ Pro Plus Control System Makes Tablet Production Easy
The Natoli AIM™ Pro Plus control system is a flexible software and hardware architecture that is standard on Natoli production tablet presses. This industry-leading package can be retrofitted to almost any production tablet press to increase production, improve tablet consistency, and provide an easier-to-manage production environment.

Natoli Engineering’s NP-P20A single-station hydraulic tablet press is a favorite for the production of injectable micropellets and for marginal formulations requiring deep-fill. The NP-P20A meets the FDA’s requirements for batch reporting and secure data management under CFR 21 Part 11 compliance.

When Time-Reduction, Cost-Savings, Quality And Reliability Matter, Ropack Pharma Solutions Is The Distribution Partner Positioned To Deliver.