Choosing a Photostability Chamber

Environmental Specialties manufactures quality photostability chambers meeting ICH Q1B guidelines. Our time proven technology has served the pharmaceutical industry for over 15 years as well as assisting other industries in developing photostability guidelines for their products. Our knowledgeable team can assist in choosing a photostability chamber to meet your specific needs.

The following items should be considered when choosing a photostability chamber.

Chamber Size

ES offers a 12 cubic foot (benchtop) chamber with a single light bank, or a 33 cubic foot (upright) chamber with three individual light banks.

Temperature Control / Humidity Control

Chambers are available with temperature only control or temperature and humidity control. The standard chamber temperature range is 20°C to 40°C. Low temperature operation at 4°C can also be provided.

ICH Q1B Options

Option 1: ES offers a custom-made full spectrum fluorescent lamp which combines visible and ultraviolet-A outputs.

Option 2: ES offers custom-made cool white and ultraviolet-A lamps to meet the specific emission guidelines.

Light Bank Configuration

ES offers both single source light banks and dual source light banks. Our 12 cu ft chamber is standard with one dual source light bank combing both cool white (CW) and ultraviolet (UV) lights. Our 33 cu ft chamber provides three individual light banks. The standard configuration is two light banks with CW bulbs and one light bank with UV bulbs. Dual source lights can be provided for any or all light banks.

Chamber Monitoring

Local display of chamber temperature/humidity and light is provided. High/low temperature/humidity/light levels are both audible and visual. Dry contacts are provided for remote monitoring of alarms. Continuous chamber monitoring can be provided via chart recorders. A 6-channel strip chart recorder can be provided to monitor temperature, humidity and light intensities. When more than 6 channels are required (multiple dual source banks), a 6-channel strip recorder can be utilized for monitoring light intensities in combination with a circular chart recorder for recording temperature/humidity.

Remote monitoring capabilities can be provided via 4-20mA output signals or RS-485 for continuous monitoring.  One signal is required for each channel.

Chamber Utilities

The chambers require 208-230 V/1ø electrical supply. RO water or low grade DI water is required for humidity controlled chambers. Condensate removal is required for humidity chambers via floor drain, condensate pump or heated condensate pan.

ES is devoted to ensuring you are completely satisfied with your photostability chamber purchase. Your questions are important and we welcome the opportunity to speak with you concerning your specific interests and lighting requirements. Feel free to call our 800 number or email our Sales associates. We will be happy to assist.

Programmable ramping chambers, also known as freeze/thaw chambers, are capable of controlled ramping of setpoints between low and high temperatures and humidities. The standard chamber has a temperature range of 2 to 70°C., with –20°C and lower capability available upon special request. The primary function of a ramping chamber is automatic setpoint change sequences which does not require manual user control or moving of product from one chamber to another. A chain of setpoints can be programmed and automatically run for days and weeks without stop.

The entire series of setpoint changes is called a "profile", and each setpoint change is called a "step". Each profile allows up to 99 steps with each step having up to 99 recycles back to a previous step for a virtually unlimited number of profile steps. To maintain a setpoint for a specified period of time is to "soak", and to change from one point to another is to "ramp".

The CCS-3000 touchscreen controller provides the following features:

Profile Status view: Provides the user with all current data related to the Profile that is currently running. The Profile Status View screen also displays the name of the current Profile running as well as the current active segment function (Ramp, Soak, Auto Start, etc.).

Profile Entry screen: Allows the user to enter step data for each Profile. Hundreds of Profiles can be stored in memory storage. The Edit menu provides Copy, Paste, Insert and Delete functions to simplify Profile entry.

Profile Run menu: Allows the user to manually run, hold or stop a profile or advance to the next or previous step.

Profile Recycle: Allows the Profile to jump between different steps within the profile. It can also be referred to as profile "looping". This is useful for repeating the same sequence of steps over and over again without having to enter them into a profile multiple times. It is valuable for life cycle testing of product in which the same temperature (and/or humidity) Profile steps need to be repeated multiple times in order to determine longevity of a product.

Guaranteed Soak Limits: Allows the operator to set a "global" band for temperature and humidity during ramp and soak steps. Ramp steps are steps where the current step setpoint is different from the previous step setpoint. Soak steps are steps where the current step setpoint is the same as the previous step setpoint. This provides a guarantee that a ramp or soak step maintains the set temperature/humidity for the specified period of time. This function is used when process changes are expected due to chamber doors opening which might drop the chamber temperature (and the product under test in the chamber) below the desired setpoint for a period of time. During the Ramp or Soak period, if the temperature or humidity falls outside of the band set in the Guaranteed Soak Limits, the Profile timer will be put on hold until the process values fall back within the band limits set. This provides a guarantee that a ramp or soak step maintains the set temperature/humidity for the specified period of time.

Profile Plot: Plots a trend of the current Profile.

Profile Auto Start: Allows the user to select the month, day, hour and minute at which a Profile loaded into the CCS-3000 control module will automatically start.

Environmental Specialties pre-programs each chamber to customer setpoint requirements and can be of assistance when entering new profiles. The CCS-3000 provides on screen Help for instructions. Each chamber comes with a detailed Operation Manual which features detailed information on the functions of the CCS-3000. ES will be glad to assist in any questions about ramping chambers by contacting our Sales Department at (800) 688-5859.

In recent years, customers have become more and more conscious of the price per square foot of storage space, energy efficiency, and the ease of installation.  As engineering firms have become more involved with environmental chamber purchases, these issues have become critical to the review of options.

When a situation arises where the chamber is small, i.e. a ‘step-in’ chamber less than 8’ x 8’ in footprint, ES recommends consideration of a large reach-in chamber in lieu of the step-in.  For information on both products, refer to the website tabs on walk-in chambers and reach-in chambers.

For a specific comparison, let’s consider the following step-in chamber scenario:

-          Overall size:  7’ wide x 6’-6” deep x 8’-6” high, 4” insulated panels; 345 cu ft interior

-          Left and right wall shelving (usable):  41.5” long x 17.5” deep x 6 tiers spaced at 12”

-          Back wall shelving (usable):  71.5” long x 17.5” deep x 6 tiers spaced at 12”

-          Overall shelving area:  ( 41.5” x 17.5” x 6 ) x 2  +  71.5” x 17.5” x 6 = 16,222 sq in. = 113 sq ft.

Notes:

- Usable shelving is slightly smaller than nominal size due to end posts and shelf edging.

- There is an allowance of approximately 38” width x 48” depth for the user to enter the room and move product into place.

Let’s compare this to a triplewide reach-in chamber:

-          Overall size:  10’-3” wide x 3’ deep x 7’-8” high, 2.5” insulated walls; 114 cu ft interior (usable)

-          Shelving (usable):  116” long x 28” deep x 5 tiers spaced at 12”

-          Overall shelving area:  ( 116” x 28” x 5 ) = 16,240 sq in. = 113 sq ft.

This example shows that a triplewide reach-in chamber, at a nominal 114 cu ft, can provide the same shelf storage area as a step-in chamber, at a nominal 345 cu ft. 

Note that the step-in chamber requires field erection, meaning that site construction and site start-up and testing is required.  The reach-in chamber, on the other hand, is factory assembled, factory tested, then shipped to site. 

Between the two options, the triplewide reach-in chamber is considerably less overall cost (materials and labor), and is a much faster installation (simply unload and roll into the final location).  Both options are energy efficient, but the cost and installation considerations make the triplewide reach-in chamber a highly favorable choice for small to medium volume storage needs.

Environmental Specialties has supplied hundreds of ‘standard’ cold rooms, warm rooms, and freezers over the past 30 years.  While this still represents a large part of the business, a growing part of the business in recent years has included cold cleanrooms and ultra low freezers.  As a Product Engineer, I find these types of rooms most interesting, and a good fit for a company such as ours with depth in engineering and project management resources.

The cold cleanrooms (40 F +/-) are a niche market for environmental chambers companies such as Environmental Specialties, understanding that standard temperature (70 F +/- range) cleanrooms are generally provided by typical cleanroom builders.  Environmental Specialties provides Class 100 to Class 100,000 cleanrooms, with internal stainless steel conditioning units or external air handlers.  Of important note, ES offers the custom internal conditioning units in order to provide a more energy efficient, cost efficient, and space efficient method of cooling and air circulation.  This unique approach has gained popularity over the years with major pharmaceutical companies, using such an approach versus the more traditional (and more expensive) air handler approach.

Ultra-low freezers have been a part of the product line for many years, but have gained more interest in the recent years as biorepository designers have become aware of, and even promote, the revolutionary designs of Environmental Specialties.  Traditional biorepositories rely upon numerous, individual reach-in chambers.  While this is easy to order through a catalog, it is not energy efficient, not cost efficient, and not space efficient.  ES offers multiple solutions for biorepositories, including multiple reach-in units operated by singular (or redundant) cooling systems, multiple chest units operated by similar cooling systems, or the popular walk-in style with multiple ultra-low compartments, operated by similar cooling systems.  The walk-in approach is extremely attractive considering that multiple storage compartments (10, 20, or more) are offered within (1) walk-in system.

Contact the Sales Department at Environmental Specialties to discuss cleanrooms, ultra-low freezers, or any other special design chambers you may require.

Brian Philbeck, PE

Senior Product Engineer