Reliable Test Methods...The Proof Is In The Data
If you do not have a reliable test method, you do not have a test method! Reliability and repeatability of PTI test solutions is a mantra that runs deep within our organization. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

What's Behind An ASTM Test Method?
Developing an ASTM standard test method is an arduous process designed to establish a test method for industry while also offering definitive precision, accuracy and reliability (PAR) statements. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

Nanotechnology Critical Cleaning For Quality & Safety
Nanotechnology is currently employed across a wide range of industrial, research, and academic applications. Stringent cleaning protocols are essential to the successful fabrication of nanotechnology particles, structures, and systems. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

Classification And FDA Regulations: Medical Device, Pharma, and Combination Products
Package integrity testing is regulated by the FDA and risk assessments determine the extent to which testing needs to occur. How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product. An important distinction is the difference between medical device, pharmaceutical products, and those considered combination products that ride the divide. The FDA recognizes a medical device as any instrument, apparatus, machine, implant or other similar article which does not achieve its primary intended purpose through chemical action (purely a device). The momen...
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

Walker Barrier Systems Builds Mobile Clean Rooms For Texas A&M Center For Innovation In Advanced Development And Manufacturing For Vaccine Manufacturing
Walker Barrier Systems, a producer of isolation and containment equipment within Wabash National Corporation's (NYSE: WNC) Walker Group division, announced today that it has built and delivered the first of eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM). Walker Barrier Systems has more than 20 years of experience providing isolation equipment to more than 100 companies in the pharmaceutical and biotechnology industries. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

Achieving Contained (Dust-Free) Milling
By James Ellis, Director, Hanningfield Process Systems The growing use of high-potency APIs has led to an increasing need for total process containment. Ingredients are often hazardous and can be dangerous to both the environment and personnel if mishandled – this is a particular concern during milling, a process often associated with dust generation. To protect both the operator and the process environment, it is important to consider how to overcome this problem, preferably without restricting throughput. Whilst there are a number of ways to achieve containment during milling, this article shall primari...
Source: Pharmaceutical Online News - April 12, 2016 Category: Pharmaceuticals Source Type: news

Amgen Looks To Air And Auto For Advice
There are roughly 38,000 components that go into building a commercial airplane; in the automotive industry, it’s about 13,000 to build a car.“That requires just a little bit of coordination,” says Rodney MacLea ofAmgen.If companies in those industries effectively manage much larger supply chains, why can’t pharma improve its performance? MacLea and Amgen set out to find out. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 11, 2016 Category: Pharmaceuticals Source Type: news

04.12.16 -- Genentech Speaks The Language Of CMOs
04/12/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 11, 2016 Category: Pharmaceuticals Source Type: news

4 Questions From The PDA Annual Meeting
A few weeks back I attended the 2016 PDA Annual Meeting held in San Antonio. In general, the main thrust of the conference focused on the technologies and approaches being applied by biopharma manufacturers as they move their therapies from development through commercialization. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

Uni-Hoist HES (Hoist Electric Stationary) Video
The Hanningfield Uni-Hoist HES is used to raise and lower a vacuum transfer hopper at the press of a button. This enables simple docking of the equipment above a process machine or lowering of the hopper to ground level for cleaning and maintenance. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

Uni-Hoist HPM (Hoist Pneumatic Mobile) Video
The Hanningfield Uni-Hoist HPM (Hoist Pneumatic Mobile) is an air-operated lifting device for the handling of containers, drums, IBCs etc. The video shows the hoist raising and lowering a Fluid Bed Dryer bowl. The bowl trolley and hoist itself were manufactured by Hanningfield, with the FBD bowl free-issued for testing. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

CapsuJet C20 (Empty Capsule Conveyor) Video
The Hanningfield CapsuJet C20 (Empty Capsule Conveyor) is a simple and efficient method for the gentle and repeatable transfer of empty capsules into the capsule filling machine. Empty capsules are manually loaded into a large diameter, low -height capsule storage-hopper. The 200-litre storage-hopper has been designed to accommodate a full, standard sized box of capsules. When in operation, a tangentially discharged airflow from a multistage fan is forced through a patented venturi. The empty capsules in the storage hopper are gradually picked up by the suction created by the venturi and gently conveyed in a low- pressure...
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

Uni-Mill M05-U Lactose Milling Trial Video
The Uni-Mill M05-U can be used to grind and mill various materials. One of the most common is lactose, which is widely used as a bulking agent in pharmaceutical and food production. Lactose can be prone to clumping and caking when exposed to moisture or stored for long periods of time. Milling the lactose can re-powderise the product ready for normal processing. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

Uni-Vac Vacuum Transfer Of Sucrose Video
The Hanningfield Uni-Vac can be used for the transfer of most standard pharmaceutical powders, such as sucrose, lactose etc.  The system offers a fast and effective method for unloading drums and bags, moving the powder to the required destination (e.g. IBC, process machine or similar).  Where necessary, the vacuum conveying system can be fully contained for dust-tight powder transfer with zero emissions. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news

Uni-Dust Cyclone Pharmaceutical Powder Recovery Video
The Hanningfield Uni-Dust cyclone is specifically designed for the recovery of waste powder from OSD processes such as tabletting and encapsulation, typically capturing 90 - 99.9% of waste powder. We have successfully installed our cyclone to Fette, Manesty, Korsch, Zanasi, Bosch, Kilian and numerous other process machines. Where required, the cyclone can incorporate a manifold for connection to ancillary equipment such as tablet dedusters or capsule polishers. Features and Benefits Specifically designed for the recovery of waste powder from tabletting and encapsulation. Stainless steel construction with no moving par...
Source: Pharmaceutical Online News - April 8, 2016 Category: Pharmaceuticals Source Type: news