Hull manufactures Pharmaceutical Freeze Dryers for both pilot and production use. Over our fifty-plus years we have developed a depth and breadth of experience second to no one in the design, fabrication, assembly, testing and installation of these lyophilizers. We design to Pharmaceutical cGMP industry standards and our control systems are GAMP 5 compliant and validatable to 21 CFR Part 11, Electronic Records and Signatures. Vessels are engineered and built to ASME section VIII Division 1 standards for unfired pressure vessels.

Hull can provide manual, semi-manual, and fully automatic loading and unloading systems for your freeze drying suite. Autolaoding speeds production, reduces risk of contamination, and enhances repeatability.

Hull can provide ASME process vessels, chambers and condensers, for your freeze dryer retrofit project. We also manufacture vacuum isolation valves, refrigeration skids, vacuum skids, Clean In Place skids, replacement shelf bundles, and control packages to help you upgrade your equipment for increased reliability and production throughput.

Why settle for a used lyophilizer when Hull will rebuild your existing freeze dryer and upgrade its controls, refrigeration, and vacuum systems to meet current requirements? We also broker freeze drying equipment and have units available for resale. Some have been refurbished and are available for immediate delivery, others can be re-finished quickly to your exact requirements.

When you buy a used lyophilizer, you may not be totally sure of what you're getting. But with Hull's Lyo Renewal group, you can be assured that your lyophilizer will live up to the Hull reputation.

We're actively seeking equipment to buy, rebuild, and resell. For further information please contact the Lyo Renewal Manager at 215-672-7800 or e-mail lyorenewal@hullcompany.com.

FREEZE DRYER INSTALLATION, MAINTENANCE, SERVICE, AND OEM PARTS

INSTALLATION SERVICES

We Provide:
-- Rigging
-- Setup and Configuration
-- Startup
-- Validation Assistance
-- Training

Your freeze dryer represents a significant investment of your time and budget. The faster your freeze dryer is installed, commissioned, and validated, the faster you can meet your production goals.

MAINTENANCE SERVICES

We Provide:
-- Warranty Service
-- Emergency Repair
-- PM Programs

Unplanned downtime is a budget killer. Minimize your downtime with Periodic Maintenance and the use of OEM parts and components.

OEM PARTS

We Provide:
-- Components
-- Sub-Systems
-- PM Parts Packages
-- Upgrades

Call and ask for our Parts department. Please have your model and serial number available.

Hull freeze dryers are carefully designed to meet the exacting requirements of the pharmaceutical industry. All components, whether purchased, modified, or purpose-built are engineered to provide the best performance and service life possible for the application. Our 50+ years of expertise allow us to provide the exact replacement parts and maintenance kits your lyophilization systems require.
Hull can provide all of the services above for other brands as well.

FREEZE DRYER PREVENTATIVE MAINTENANCE (PM) PROGRAMS

Hull will provide a Field Service Engineer who will visit your facility to perform scheduled lyophilizer preventative maintenance. Maintenance will typically be scheduled on a semi-annual basis to assure proper freeze dryer maintenance, conformance to equipment warranties, and to maximize system reliability and performance. The duration of the visit will be determined based on the service outlined below and your specific system configuration.

Parts are typically required for preventative maintenance. Hull will verify an applicable parts list and have them ordered and on-site prior to the arrival of the Field Service Engineer.

ANNUAL/SEMI-ANNUAL PREVENTATIVE MAINTENANCE PROCESS

Review maintenance documentation from previous preventative maintenance visits and/or the customer's maintenance history file. Then perform the following checks: (Representative Sample Only - Actual list is based on your specific freeze dryer configuration)

Preventative Maintenance - Lyophilizer Items Check List:

• Leak Check
• Compressor valve plates
• Compressor oil
• Clean Condenser / Receiver
• Inspect Vacuum Pump
• Inspect Heaters
• Readout & Recording
• Lubricate Motors
• Replace Transfer Fluid Filter
• Replace Refrigerant Filter(s)
• Inspect Electrical Components

Preventative Maintenance- Lyophilizer Operational Check List:

• Manual switch operation.
• Operating/energizing all components in an on/off manner.
• Hydraulic operation
• Shelf operation (movement)
• Function Testing - temperature and vacuum rate performance
• Leak Rate Test
• Filling / charging fluid systems as required.
• Tuning control parameters will be documented.

The entire freeze dryer Preventative Maintenance process will be documented by the Field Service Engineer using a system-specific lyophilizer Preventative Maintenance Checklist.

Hull recognizes that each freeze drying system and site is unique. Therefore, we custom tailor each and every contract to best suit your specific needs. We are always focused on cost effectiveness, timeliness, and maximizing your uptime.

BLOCK OF TIME SERVICE CONTRACT

A block of time service contract is a commitment for at least 100 hours of maintenance performed by a trained Field Service Engineer, to be used in a twelve month period at your discretion.
The Benefit to You:
You receive priority scheduling and a discounted service rate of 15%. Use this service for troubleshooting, repairs, or maintenance as you need it.

HULL LYOPHILIZER PATENTS

Hull delivered its first freeze dryer in 1958. Since then, Hull has delivered over one thousand pilot and production lyophilizers. The experiences gained from meeting our customers' broad range of freeze drying requirements has enabled Hull to make frequent advances in lyophilizer technology. Many of these innovations have been patented and are incorporated in our State-of-the-Art equipment:

USP 5,743,023 Method and Apparatus for Controlling Freeze Drying Process

Control of temperature of the shelves in a freeze dryer compartment is achieved by circulating a cooled heat transfer fluid from a heat exchanger through a vacuum condenser independently of circulating the cooled heat transfer fluid either directly through the passageway chambers in the freeze dryer shelves, for cooling the shelves, or through a heater for heating the shelves. These circulations are effected by the selective control of electrically operated valves in fluid conduits automatically by a programmed computer.

USP 5,421,686 Automatic Vial Loading and Unloading System

A system for automatically loading and unloading (without operator assistance) bottles, vials, or other containers into and out of a freeze dryer includes a loading station and a conveyer for bringing the bottles to the loading station. A movable transfer vehicle transports the bottles between the loading station and one or more freeze dryers. An unloading station then completes the Hull Automatic Loading "HAL" system.

USP 5,330,157 Rotary Disk Valve

The arrangement of drive shaft, valve disk support shaft, bracket slot and guide cam and follower is such that the rotation of the drive shaft through 180 degrees in one direction first moves the valve disk out laterally from closed and sealed position to an intermediate position spaced from but parallel to the valve seat surface, and then rotates the valve disk 90 degrees to a full open position. Reverse rotation of the drive shaft moves the valve disk from open to closed position. This type of valve design completely eliminates the adverse generation of particulate matter resulting from the outside diameter of the valve disk scrubbing against the valve liner in order to effect a seal. Also, it eliminates frequently encountered maintenance problems with valve liners associated with butterfly and other valve types.

USP 5,236,041 Cyclonic Vapor Flow Condenser

A condenser arrangement that includes a three stage cyclonic vapor distributor and a plurality of cooling surfaces arranged in an optically dense configuration for high sublimation rate performance. When used with plate type cooling coils, this configuration allows all surfaces to be directly exposed to cleansing fluids introduced into the condenser body from a minimum number of direct spray nozzles. This type of condenser is currently referred to as Hull's " HYPRO " condenser.

USP 5,037,147 Latching System for Chamber Door Access

The freeze dryer "Wedge-Loc" door is secured in a closed position by a latching mechanism provided on each of four sides of the chamber flange. Each latching mechanism includes a plurality of wedges which are moved by individual hydraulic cylinders into a sliding and wedging engagement with corresponding fixed wedges mounted on the door.

USP 4,961,273 Method and Means for Assuring Freeze Dryer Chamber Sterility

The shelf-operating piston rod of an hydraulic cylinder of a freeze dryer is prevented from possibly contaminating the freeze dryer chamber and product by enclosing the piston rod within the chamber with an impervious flexible sleeve capable of extending and retracting with the piston rod.

USP 4,736,691 Container Stoppering Apparatus with Adjustable Shelves

A chamber containing a plurality of vertically spaced shelves movable vertically relative to each other upon activation of a fluid pressure piston-cylinder unit mounted on the chamber housing. Elongated suspension rods depend upon the top shelf to support the next two adjacent shelves for relative vertical movement. The support arrangement allows the shelves to be adjusted to different spacings.

USP 4,624,512 Processing Cabinet with Subdoor Access

The main door of a freeze dryer is provided with a sub-opening arranged to register with the space between adjacent vertically adjustable freeze dryer shelves for infeeding and outfeeding trays or other containers of material to and from each shelf. Safety systems are provided with the entry passageway to prevent closing of the subdoor when any object is in the entry passageway.

USP 4,461,946 Apparatus for Clamping an Assembly of Parts for Laser Welding

A manufacturing method for the fabrication of freeze dryer hollow shelves with greater precision, speed and facility than currently practiced by the industry. An assembly of top and bottom plates spaced apart vertically by peripheral and intermediate spacer bars forming a shelf of freeze drying or other processing equipment is held together on a movable base support by peripheral clamps mounted removably at selected positions on the base support. A laser welder then is moved relative to the clamp assembly to weld the components together in the clamped areas. The process can be quickly repeated to minimize the introduction of any residual thermal stress to the shelf caused by the welding process that could cause warpage after years of in service use.

USP 3,537,233 Container Stoppering Apparatus

The original Hull patent describing a freeze dryer chamber adapted to have top and or bottom hydraulic cylinder driven piston units between which are positioned a plurality of vertically movable product shelves for the purpose of stoppering product bottles and vial containers.

USP 3,461,953 Vacuum Dryer Shelf Temperature Control

Patent describes a basic concept by which a heating fluid is circulated through the shelves of a freeze dryer periodically in opposite directions, whereby to maintain a substantially constant and uniform temperature over the entire area of the shelf. Forerunner of Hull's SMART COOL technology.

USP 3,381,746 Vapor Condensing Apparatus

A cylindrical vapor condenser having a hollow housing forming inner and outer subchambers in which vapors from the freeze dryer chamber are caused to pass through the condenser unit from inlet to the outlet in a countercurrent flow path.