Sunday, April 30, 2017

Depyrogenation Ovens

depyrogenation oven with HEPA filtration diagram
Air flow profile of a cGMP depyrogenation oven
Courtesy Lytzen A/S
Manufacturers of pharmaceutical products intended for parenteral administration to humans are keenly aware of the stringent quality standards, production process challenges, and regulatory requirements impacting their work. One area that is common to all parenteral products is the delivery of pyrogen free finished goods, as determined by approved testing procedures.

Pyrogens are substances that produce a temperature rise, or fever. They are generally described as endotoxins or exotoxins associated with bacteria. The subject of pyrogens, their nature and source, is well beyond the scope of this article. The focus here is on how to rid them from pharmaceuticals, specifically the containers in which they may be shipped, stored, or handled.

The sterile and pryogen free bulk parenteral final product needs to be dispensed into appropriate containers for shipping, storage, then handling, right up to point where it is administered to the subject. The containers must be pyrogen free, just like the product, in order to avoid any contamination. One way to accomplish this is with a heating process that assures destruction of pyrogens while protecting the processed items from other sources of contamination.

Of course, only items that can tolerate the necessary processing temperatures without destruction can be heat processed. The majority of dry heat processed items will likely be glass containers. A typical depyrogenation oven cycle might look like this:

  • Drying - Air circulation and possibly some heat, along with introduction of fresh air through a filter, to assure that the load is fully dry.
  • Load Heating - Once conditions have been achieved that indicate the load is fully dry, heat is applied to raise the chamber temperature to the required processing temperature.
  • Load Exposure or Soaking - The load within the chamber must attain a minimum temperature for a minimum amount of time to assure the minimum pyrogen level reduction is achieved.
  • Load Cooling - After the required exposure has been achieved, the load mass will have a substantial amount of stored heat. The removal of this heat can be achieved with filtered ventilation air or a water coil integral to the oven.
The basics are simple, but each production operation will face specific challenges related to their product, facility, and operation. Intricacies of oven air movement, load handling, filtration, sealing, process validation, and many other aspects will come into play in establishing a depryogenation process that fulfills the entire range of regulatory and organization requirements.

Share your biopharm processing challenges with knowledgeable professionals. The combination of your own process knowledge and experience with their product application expertise will yield an effective solution.

Wednesday, April 19, 2017

Filtration and Biological Safety Cabinets

biological safety cabinet
One of several variants of biological safety cabinet
Courtesy Esco
Biological safety cabinets (BSC), of which there are several specific types, are purpose specific safety equipment enabling technicians to work with limited types of biohazards. They provide containment of the hazard while delivering a clean work space that, along with proper technique, minimizes the contamination probability of cell culture work in progress.

Arguably, the heart of the BSC is a set of filters that efficiently trap and hold particles in the recirculating and exhaust air streams. These filters keep airborne pathogens out of the work zone, but contained within the cabinet. Some manufacturers utilize HEPA filters, while others employ the higher efficiency ULPA filters.

HEPA filters are rated and tested in accordance with accepted standards to deliver efficiency levels of 99.97% when challenged with a test aerosol containing 0.3 micron diameter particles. HEPA filters are essentially depth filters, composed of a dense array of microfibers capable of trapping or preventing passage of very small particles. ULPA filters utilize a similar microfiber media that provides a performance level of 99.999% efficiency on particles of 0.1 microns. The higher efficiency and lower contained particle size for ULPA filters is considered and advantage by some.

Biological safety cabinets and their filters, regardless of type, both have very specific standard testing procedures for finished product to assure proper safety performance. Proper handling and installation of the equipment is necessary to avoid even minor invisible damage that could impact equipment performance. In place testing of newly installed or relocated biological safety cabinets is good practice, required in many cases.

Determination of the right type or class of safety cabinet for specific applications is the role of qualified safety specialists. Once the proper type of biological safety cabinet is established for a lab, choosing a specific manufacturer and model that provides the operational features and work space that best suits the user can be facilitated by consulting with a laboratory equipment specialist. The combination of user experience and laboratory process knowledge, with the product application expertise of a specialist, will yield an effective solution.

Wednesday, April 12, 2017

Flexible Installation and Dispensing Options for Lab Water Purification Unit

laboratory water purifier modular unit
Chorus modular laboratory water purification
unit, shown with dispenser integrated to bottom
Courtesy Elga LabWater
As a laboratory technician, researcher, or operator, purified water of a known and consistent quality is as essential as drinking water. The production and dispensing of purified water is a support task or operation that, while necessary, does not move the lab mission forward in a direct way. Ideally, water of the right quality will be available for dispensing on demand and lab personnel will not need to spend time checking, adjusting, or maintaining the water production and storage apparatus.

The Elga PURELAB® Chorus modular water purification units for laboratory use provide a number of features and options that enable the production and dispensing of Type 1 ultrapure water effectively and ergonomically.

  • Several unit variants allow the user to select the combination of water purification technologies that best suit their laboratory needs.
  • Dispensing options configure the interface between user and equipment in a manner that best suits the way technicians will dispense purified water.
  • On board monitoring of component performance and water quality provide indication of when purification elements require replacement and confirm water quality and the point of delivery.
Below is a datasheet for the PURELAB® Chorus modular water purification units, showing all the available configurations and dispensing options. Share your lab water requirements with application experts, combining your own laboratory experience and knowledge with their product application expertise to develop effective solutions.

Friday, April 7, 2017

Atlantic Technology Group at Chesapeake Bay Chapter ISPE Conference

engineer speaking with customer about process equipment at showcase exhibit
Tim Holden, of Avant Garde Scientific, speaks with an attendee at the
2017 ISPE Chesapeake Bay Chapter Mid-Atlantic Life Sciences Showcase
Atlantic Technology Group continued its corporate sponsorship of the ISPE Chesapeake Bay Chapter this week at the 2017 Mid-Atlantic Life Sciences Showcase held at the University of Maryland Shady Grove Campus. In addition to the educational portion of the program, there was an evening get together with a keynote speaker and various exhibits of service and equipment vendors. It was a great opportunity for participants in various facets of the industry to come together in a casual environment and share ideas and experiences, and generally have a good time among others within their professional community.

ATG showcased technical aspects of their product offerings from:

  • Miele Professional - Specialized washing equipment for glass and plastic ware
  • Girton - cGMP washing equipment of standard and custom design
  • Elga - Point of  use water purification equipment
  • Esco - Biologial safety cabinets, specialty laminar air flow stations and equipment
  • BMT USA - cGMP sterilizers and ovens
On hand were David Jenkins, president of ATG, and Tim Holden from Avant Garde Scientific. Avant Garde sells and services the Atlantic Technology Group product offering in Maryland and the metro Washington, DC area.

A great organization, great event, very productive for everyone attending.