White Papers

Since January 1995, medical devices to be marketed in the European Union (EU) have been required to comply with EU Medical Devices Directive (MDD), which specified requirements for safety assessment issues. The initial purpose of the directive was to promote a single European market for trade in medical devices, while…

Risk assessment is a key component in the approval process for a new medical device. The International Organization for Standardization (ISO) 10993 series of standards is recognized by regulatory bodies throughout the world and applies when a medical device comes into contact with the body directly or indirectly. Both ISO…

Matcon – IDEX India
Choosing the ideal IBC system to meet your needs can difficult. Whilst you want to ensure that your provider understands your requirements, you also need to adhere to the highest industry standards. To help you ask the correct questions of your IBC provider, we've developed the Ideal IBC System Checklist.…

Matcon – IDEX India
Embracing and investing in new technologies is one way to get ahead, and adopting lean, efficient manufacturing procedures is another. At a fundamental level, achieving efficiency can start at the outset of a project by considering the very design of a production facility. Careful planning can cut costs and reduce…

SunWay Biotech Co., LTD
ANKASCIN® 568-R answers the call for a safe and effective red yeast rice supplement ingredient, since it includes the active compounds beneficial for heart health and no monacolin K. Backed by myriad clinical trials, the ingredient is FDA approved as a new dietary ingredient and holds 28 patents worldwide. And,…

Matcon – IDEX India
Still handling tablets in drums? It is common to find Intermediate Bulk Containers (IBCs) being used for handling powders and granules in solid dosage manufacturing processes, from initial Dispensing through to Tablet Compression or Capsule Filling. The benefits of using IBCs for efficient and flexible materials handling at this stage…

Dividella AG
MedImmune wanted to respond to the voice of the customer who was requesting a new unit of sales – Single Unit Dose package. This new package format for a nasal administration live virus fl u vaccine must be stored at sub-zero temperatures (-25 deg C) and shipped at - 80…

Dividella AG
Flu vaccines are a high volume commodity product, in which price, availability, and Time-to-Market are key factors for success. The entire production for the flu season takes place within a 3-4 month period. Production operates on 24/7 basis. In addition, vaccines are shipped and stored in a cold-chain. This requires…

Dividella AG
The very best of technology which has proved itself over many decades, adapted to new packaging requirements – this was what the customer wanted. The NeoTOP 304 packaging machine from Dividella AG, which has just been fully upgraded, features greatly increased flexibility, to the customer’s delight.

ViscoTec Pumpen- u. Dosiertechnik GmbH
Independent of viscosity, shear-sensitive and high-precision Conventional filling technologies such as piston or peristaltic pumps reach their limits when filling small quantities of viscous, medical or pharmaceutical products – such as gels, ointments, hyaluronic acid and polymers – with precision. Solids and abrasive products are used to be effect in…