Pharma Times - Vol 40 - No. 11 - November 200830

Stability Chambers : A guide to correct selection andoperation

SELECTION OF STABILITYCHAMBERS

Stability Studies is very importantin the Pharma Industry. Itsubstantiates on how the drugsubstance or product quality varieswith time under environmentalconditions during distribution andstoring. ICH Guidelines are availableto give details of the studies to bedone on the product and to check howstable the product is under variousenvironmental conditions.

To perform stability studiessuccessfully, one has to have a goodquality stability chamber with all thespecifications to meet the RegulatoryGuidelines of WHO, US-FDA, UK-MHRA and other regulatory bodies.

Therefore, the selection of thechamber is significant to performstability studies.

SPECIFICATIONS AND OPTIONSAVAILABLE IN CHAMBERS :

Stability Chambers are availablein various sizes and volumes from 90ltrs. to 1000 ltrs. as StandardChambers and Customised madeWalk In Chambers of differentvolumes made to fit in the specifiedspace available on site.

Control Specification available :

Temperature Range :20 deg. C to 60 deg. C

Temperature Accuracy :± 0.2 deg. C

Temperature Uniformity: ± 2 deg. C

Humidity Range :

40% to 98% RHHumidity Accuracy : ± 2% RHHumidity Uniformity : ± 3% RH

Recording System :

Stability Chambers are availablewith recording systems to record theset temperature, actual temperature,set humidity and actual humidity withdate and time.

Following are the Options:

1) Printer Interface facility to recorddata directly on the PC.

2) PC Interface facility to downloaddata on PC using 21 CFR part 11Compliant Software.

3) Strip or Circular Chart Recorder.

4) Data logger with multiple probesfor temperature and humidity, tocheck uniformity of the setcondition across the chamberunder loaded condition.

The Chambers should runcontinuously for 365 days without failto have an accurate analysis. Tofacilitate this, the Chambers are nowavailable with Stand by RefrigerationSystem and Stand by HumiditySystem, which starts immediately incase the regular systems fails. Thiswill avoid the down time and thechambers will give uninterruptedstability studies.

Data Acquisition software isavailable with compliance to 21 CFRPart 11 (US-FDA Requirement).

The chambers are available withvarious safety features such as :

1) Float switch to cut off the mainsupply in case of low water levelin the boiler tank.

2) Dedicated safety controller withseparate sensor to cut off thesupply in case of overshoot and

undershoot of condition givingaudio visual alarm.

3) Additional safety thermostat to cutoff the supply in case of overshootof temperature.

4) 2 min. compressors 'ON' delaytimer to safe guard thecompressor.

CHAMBER SELECTION :

Selection of a Stability Chamberis very important after considering themanufacturer of the chamber,chamber specifications and volumeselection.

It is always recommended to buythe equipment from a technicallysound manufacturer, whounderstands the requirement andcriticality of Stability Studies, withgood infrastructure to support thequality of chamber as well as AfterSales Service (local service personshould be available for maintenance).

Sandip MhatreDirectorThermolab Scientific Equipments Pvt. Ltd.

Article

Pharma Times - Vol 40 - No. 11 - November 2008 31

The chamber volume is selected

as per the Test Sample load and also

as per the set condition required.

Example: For a given condition 25

deg. C and 60% RH, the test duration

is of 2 years thereby giving less

turnover of the samples. Hence, in this

case, the user should consider large

volume chambers to small ones.

The Stability test equipment must

be capable of controlling temperature

to a range of ± 2 deg. C and Humidity

to ± 5% RH (as per US-FDA

requirement). However, the chamber

should preferably give control of ± 0.5

deg. C and ± 2% RH and uniformity

of ± 2 deg. C and ± 3% RH under

loaded conditions.

Recording the temperature and

humidity conditions is a must for all

the Stability Chambers and the

records must be preserved.

It is always recommended to have

a stand by refrigeration system and a

stand by humidity system so as to run

the chamber continuously avoiding

down time in case the regular system

fails.

All the safety systems should be

incorporated in the chamber so as to

protect the chamber, testing samples

and the person working on the

chamber.

The Mobile Alert system and the

Door Access Security system will give

added features to the chamber.

However, they are not mandatory and

do not deter the performance of the

chamber.

CHAMBER VALIDATION ANDCALIBRATION:

The chamber should be

calibrated and validated and the

qualification documents should be

maintained and preserved so as to

present the same to the regulatory

authorities when required. The

documents should be inclusive of the

following:

A) Design Qualification :

1) User and Functional requirement

specification

2) Basic Documents

3) Data Sheet for Design

Specification and Verification

4) Approval

B) Installation Qualification :

1) Test Verification of stability

chamber details

2) Verification of design

documentation

3) Verification of calibration and test

certificates

4) Verification of system utilities

installation

5) Verification of standard operating

procedure

C) Operational Qualification :

1) Test verification of stability

chamber details

2) Verification of standard operating

procedure

3) Verification of operation of stability

system

4) Verification of training records

5) List of supporting documents

D) Performance Qualification:

1) Test verification of stability

chamber details

2) Test verification of performance

stability system

3) List of supporting documents

The above should consist of

supporting documents such as

component test certificates, mapping

diagram, chamber diagram, electrical

diagram and refrigeration diagram

and so on …

MAINTENANCE OF THECHAMBER:

The Chamber is suppose to work

continuously, and hence, following

points are imperative:

1) To fulfill all the Installation

Requirements such as

uninterrupted and stabilised power

supply, DM or RO water supply,

dust free and ventilated room

(below 30 to 35 deg. C), UPS or

stabilized power supply to the

control system.

2) An Engineer should be identified

to do all the maintenance work.

The Training should be given by

Chamber Manufacturer.

3) It is also suggested to enter into

an Annual Maintenance Contract

(AMC) with the Manufacturer or to

make a Preventive Maintenance

Program.

4) To keep some essential spares on

site.

From the above synopsis, we

conclude that for an Intensive stability

studies a user must consider good,

sturdy, enduring, reliable equipment

with standard components; extensive

validation; comprehensive docu-

mentation to be accepted by all the

regulatory bodies and last but not the

least, timely local After Sales

Services.

CORRIGENDUM

In the October 2008 Issue, wemissed giving the authordetails for the article on “MeanKinetic Temperature”. Theauthor of the article KennO’Donnell is Direcor & ChiefTechnical Advisor to Industryfor Tegrants Corporation,ThermaSafe Brands.TheEditor regret this oversight.