INSIGHTS ON SOLID DOSE MANUFACTURING

  • Ensuring Safe Handling Of High Potency Products

    Due to the high potency of the pharmaceutical active ingredients (APIs), machine operators have to be protected and while at the same time, humans are a high source for product contamination. In pharmaceutical manufacturing facilities, isolators are becoming increasingly important as they can achieve the desired level of protection and security. This article presents a fully integrated highly complex isolator and process equipment solution offering high safety, efficient control and cleaning features as well as full compliance in terms of manufacturing regulations.

  • Flexible Isolator Technology – Containment That Works

    This webinar focuses on applications where flexible isolators have been used, including containment assessments to confirm performance and ergonomic benefits. 

  • New Technologies For Safe And Contained Powder Handling In The Bulk Pharmaceutical Industry

    Powder handling plays a major role in the design and the operation of an API facility, and can often become the “bottle neck” of the plant. The constantly increasing toxicity and reactivity of products in recent years as well as the ever more demanding production standards with regard to quality have made closed powder handling an unavoidable factor and manual handling obsolete. Selecting a suitable technology has become vital for the development of a project since it can largely influence the entire design.

  • 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.

  • Managing Risks With Potent Pharmaceutical Products
    7/2/2019

    Any drug manufacturing facility handling potent compounds must be equipped with the appropriate methods, controls, and expertise to ensure the safety of its employees and the integrity of its product. Managing these risks requires a knowledgeable team as well as the design and implementation of an effective safety program.

  • Drug Product Advancement - A Path Through Development By Powder In Capsule Approach
    5/11/2020

    Using micro-dosing technology and powder-in-capsule (PIC) or powder-in-bottle (PIB) approaches, biopharmaceutical companies can increase speed to clinic, quickly assess their candidate compounds, and remain cost-conscious in early stage development.  In this webinar, Lonza experts review best practices PIC and PIB challenges and discuss rapid encapsulation transfer from clinic to commercial scale.

  • Enabling Enteric Protection And Rapid Release In The Upper Small Intestine
    10/5/2020

    Enteric coatings have been utilized with oral drug products for more than 60 years to protect acid-sensitive APIs from gastric acids and prevent gastric irritation by aggressive APIs. However, for many complex drug products targeting the small intestine or ileocolonic region, enteric protection on its own is insufficient to maximize absorption and enhance bioavailability. A new and unique oral drug delivery technology could be the solution.

  • Five Tests For Pharmaceutical Containment
    3/13/2020

    As active pharmaceutical ingredients increase in potency and become more hazardous to work with, pharmacological and chemical containment devices are required to meet containment performance targets through independent testing before use in laboratories can begin. Typically, we test containment equipment against some minimum performance standard. This is necessary to protect procedural integrity and the sensitive products undergoing processing.

  • Selection Criteria For Ribbon, Vertical, Or Tumble Blenders
    2/4/2020

    Among solid-solid blending systems, the three most common types are the horizontal ribbon blender, the cone screw vertical blender and the tumble blender. Aside from level of shear or ‘gentleness’, other factors help determine which type of blender will work most efficiently in a certain application. Following are some things to consider when choosing your blender.

SOLID DOSE MANUFACTURING SOLUTIONS

  • Used Fuji Paudal Marumerizer spheronizer, model QJ700, stainless steel construction, with 2.0 mm grooved spheronizing plate with plate lift mechanism, jacketed bowl, side discharge with pneumatically operated plug valve, on base, serial 20050, built 1990.

  • Used Powrex high shear mixer, model FM-VG-25, stainless steel construction, 15 liter working capacity with high speed chopper driven by 1.5 kw motor, main shaft driven by 3.7 kw motor, with controls, serial# 903222, built 1990.

  • NU-560 Total Exhaust Biological Safety Cabinet (BSC) may be used for work with non-flammable, non-explosive volatile chemicals and radionuclides by providing personnel, product, and environmental protection by exhausting 100% of contaminated air. LabGard® ES offers economical operation through the use of an ultra-high efficiency motor to maximize filter life and monolithic silicone-free construction for long product life all for an affordable price.

  • Recent years have shown steady growth in manufacturing sterile, high potent products in the pharmaceutical industry. Antibiotics for intravenous or intramuscular injection in powder form such as Ceftriaxone Sodium for example, need to be produced under sterile conditions.

  • Today, manufacturers are optimizing open-suite facility design to maximize throughput and profitability. EZ BioPac® is meeting the challenges of biopharmaceutical powder manufacture.