• What is Photo stability chamber :

Photo Stability Chambers are specially designedchambers which is climatic chambers to carried out by means of lighting capable of simulating sunlight. For this purpose a set of phosphorescent and UV Lamp is implemented that emits both visible light and ultraviolet radiation.

  • Why Photo stability chamber :-

Sunlight is the powerful force. The sun emits radiation which includes UV radiation too. These rays are capable to break molecules bonds in object. As these compounds are exposed to sunlight , the chemical bonds are broken down , causing the colors to fade. This color-changing effect is known as photo degradation. However the color of the object is not the only thing affected. The chemistry of the object is also affected. So these effects are extremely important to the pharmaceutical, cosmetic and nutriceutical industries. These sunlight conditions can be stimulated in photo stability chamber.

  • Uses of the Photo stability chamber.

Chemical breakdown in medication , cosmetic and vitamins need to be avoided. So it is critical that Compound need to be stable for duration of their shelf-life when exposed to light. This is done by testing photostability of the product. Photostability can affect shelf life, Handling and packaging of the product. This study is important in part of drug development studies.

  • How photstability studies are carried out?

The photostability studies first carried out on compounds. If the compound fail than it need to reformulate the compound and if the passes than it goes for initial packaging . Again we need to do photostability studies and if it fail need to redesign the packaging and if it passes than go for Marketing packaging. Again need to do photostability studies , if it fail need to redesign Marketing packaging and if it passes , go for sale in Market.

  • What is the Photo stability Guidelines :

    ICH Guidelines ICH-Q1B , WHO Guidelines, cGMP guideline for shelf life study.

  • Photo stability chamber conditios:
Parameter Name As per ICH Guidelines Hamco Range
Temperature 25 C 15-45 C
VIS Accumulated 1.2 Million Lux 1.2 Million Lux in 3-4 days
UV Accumulated 200 Wh/m2 200 Wh/m2 in 3-4 days
  • Hamco Photo stability chamber details.

Hamco Photo stability chamber has

  • Temperature Range 15 to 45 C , with accuracy +/- 0.2 C and Uniformity of +/- 2 C
  • Humidity Range 40 to 95% Rh, with accuracy of +/- 1% Rh and Uniformity of +/- 3% Rh.
  • VIS Intensity of approx. 18-20 Klux/hr and can achieve 1.2 Million lux in approx. 60 Hrs.
  • UV Intensity of approx. 3-4 Wh/m2 and can achieve 200Wh/m2 in approx. 50 Hrs.

Note: In photo stability studies Rh condition is not require but Hamco provides RH conditions as normally photo stability studies are of short duration and if you want to use this chamber as stability chambers you can use it.

  • Photo stability chamber calibration for VIS and UV Light.

Hamco provides calibrated Lux meter and UV meter to carry out 9 point calibration studies in Photo stability chamber and take average of it.

  • Why 21 CFR Software compliance require?

The major challenges that the auditor has that all the data submitted of the testing should be authentic and non tempered. This will only possible if it is 21 CFR Complied data is there. Thats why it is important to have stability chamber with 21 cfr complied compliance.

  • What is DQ,IQ,OQ,PQ documents?

Normally Manufacture gives the User set of documents or say checklist kind of documents which on completition of doing will check the Stability chamber thoroughly on all the parameters.

Terminology Full Form Use
DQ Design Qualification This confirm that How de design the chamber and why certain component has been selected.
IQ Installation Qualification This confirm How to Install the equipment by checking all the component Make, sl No and certificate, Preinstallation requirement and Utilities.
OQ Operational Qualification This confirm the operation wise checking of all the paramenter of the equipment.
PQ Performance Qualification This confirm the performance qualification of the stability chamber.
  • What is Validation of the chamber and its protocol?

Validation means checking the performance of the chamber on accuracy and uniformity by placing sensors at different location for specified time interval and checking report for its Confirmatory. Normally Validation will be Onsite ( Checked by the Manufactory on its location ) and offsite at Buyer location. It will be empty, Part load and Full Load depending on the validation protocol.

  • Why Hamco?

Hamco has reach experience in designing and manufacturing Photo stability chamber since last 15 years. We are having more than 1000 successful installation in India and globe. We are strong service support with In house manufacturing and software design capabilities.

  • Type of Photo stability chamber.

Hamco is making below said Table series stability chamber

Series What it Includes Benefits
PID Series Hamco 43 Series Chamber Only. No USFDA, WHO , GMP Compliance
Normal series Consist of Chamber (Hamco 43 series) + RS 485 communication Card (PCI-1) + Data Logger (RCR-11 + SOFTD-21 (Desktop browser based Software Part 11 21 CFR )

 

WHO Complied
ECO Series Consist of Chamber (Hamco 43 series) + RS 485 Communication card(PCI-1) + HMI PLC ( 4.3 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web based Software Part 11 21 CFR ) WHO, USFDA, GMP Complied
Premium Series Consist of Chamber (Hamco 43 series) + Ethernet Based Connectivity + HMI PLC ( 7 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web browser based Software Part 11 21 CFR ) +VIS-LUX Meter + VAL ( Validation)

 

WHO, USFDA, GMP Complied.

Redundency for Failure of any component for Long studies.

Scanner for Auto validation of the chamber.

Mobile and E-mail alert for critical alarm to deliver on mobile or e-mail.

Photo Stability Chamber Manufacturer in India

The Purpose of Photo Stability Chamber Manufacturer in India is to provide evidence on the how the quality of drug substances or drug product varies with time under the influence of environmental factors such as temperature, humidity and light and to establish a re test period for the drug substance or product under recommended storage conditions. Hence photo-stability chamber serves as an important Quality attribute of the product.

HAMCO Make GMP photo- stability test chambers are especially built to Pass FDA and ICH Q1B compliance standards and have a reputation for reliability, quality and performance. Exceed FDA/ICH guidelines for long term , intermediate and accelerated stability studies.

A state of the art Photo-stability chambers are available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour. Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days. The UV study is done simultaneously. Separate switches are provided for incandescent & UV light sources.

  • Temperature Range 5.0 °C to 60.0 °C. Accuracy +/- 0.1 °C. Uniformity +/- 1.0 °C
  • Humidity range : 25% to 95% RH, Accuracy +/- 3% RH , Uniformity +/- 3% RH.
  • Lamp type : Floroscent.
  • UVA Intensities: 1.8 W/m² (requires about 111 hrs achieving ICH recommendation of 200W-hr/m²)
  • VIS Intensities: 12 Klux (requires about 100 hrs achieving ICH recommendation of 1.2 million lux-hr)
  • Temperature Display : Digital LED 3 ½ digit, Resolution 0.1 deg C
  • Humidity Display : Digital LED 3 ½ digit, Resolution 1% RH.
  • Heating system: U shaped Nichrome wire heater in SS Sheathing.
  • Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant .
  • Humidity system : Non condensing type steam injection system with water level arrangement with insulation to save heat energy.
  • Air circulation : Flange Motor with Impeller and blower.
  • Interior Illumination for working Area.
  • There will be two nos of blower from 450 Ltr Onwords.
  • Double walled , gap between walls filled with PUF Insulation.
  • Standard Model : Stainless steel Mirror polished chamber and heavy guage Powder- coated CRC exterior.
  • GMP Model : Stainless steel Mirror polished chamber and exterior of dull finish stainless steel.
  • Double door : Inner full Viewing door and outer door insulated with lock and key arrangement.
  • 50mm Validation Port with silicon rubber seal to insert sensor for validation purpose.
  • 3” Thick CFC Free Puff Insulation.
  • Stainless steel Trays. Adjustable Tray Height adjustment.
  • Unit Mounted on castor wheels with front lock arrangement.
  • Microprocessor based PID temp. controller with auto tune facility for precise control of temperature and humidity.
  • Temp. Sensor : PT- 100 , RH sensor : direct capacitance type.
  • Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm.
  • Recorder data bank to store and print set values , process values , date and time of master controllers with variable print time intervals ( Optional)
  • Alarm : Audio visual alarm if temperature deviates from the preset temperature.
  • PC Interface communication card with RS 485 for temperature and humidity control system ( Hardware only) ( optional)
  • Over heat temperature and humidity cut off with alarm.
  • Low temperature and humidity alarm.
  • Low boiler water level safeguard.
  • Electrical overload compressor cutoff.
  • Time delay for compressor switch on.
  • Electrical short circuit breaker.
  • Distilled water or DM Water Line. ( consumption will be 20 ltrs/24 hrs upto 450 ltr Model )
  • Room temperature around machine preferably at 25 degree C.
  • Stabilised input voltage of 230V Ac, 50 Hz, 20 Amps.
  • Water drain line with ½” Nozzle to be provided at floor level.
  • 21 CFR Part 11 compliant software with audit trial ( who did what and when is recorded)
  • Multilevel Passwords.
  • Data storage device has online and offline capabilities.
  • Multi chamber data acquisition on single software.
  • Tabular and graphical report, alarm deviation report.
  • Mean Kinetic temperature report and alarm deviation report.
  • Audit trial report.
  • Attractive reports and graphs.
  • Alarm report.
  • Time synchronisation.

Ordering Information:

MODEL NO. CAPACITY DIMENSION IN CMS SHELVES WT IN KG POWER
Standard GMP Cu. Ft Litres Chamber Over All Unit Packed in wooden case VAC Hz Watts
HAMCO44S -3 HAMCO44 G-3 3 90 45x45x45 60x95x110 2 110 165 230,50 1500
HAMCO44 S-4 HAMCO44 G-3 4 120 45x45x60 60x95x125 2 125 185 230,50 2000
HAMCO44 S-8 HAMCO44 G-8 8 200 60x60x60 80x110x125 2 170 240 230,50 2500
HAMCO44 S-12 HAMCO44 G-12 12 324 60x60x90 80x110x155 3 200 270 230,50 2500
HAMCO44 S-16 HAMCO44 G-16 16 450 60x60x125 80x130x175 4 275 355 230,50 4000
HAMCO44 S-21 HAMCO44 G-21 21 600 60x80x125 80x130x195 5 295 375 230,50 4000
HAMCO44 S-28 HAMCO44 G-28 28 800 80x80x125 100x130x210 5 325 415 230,50 4500
HAMCO44 S-34 HAMCO44 G-34 34 1000 80x80x155 100x130x220 5 350 450 230,50 4500
HAMCO44 S-53 HAMCO44G-53 53 1500 60X160X150 110X170X210 10 375 475 230,50 5000
HAMCO44 S-70 HAMCO44G-70 70 2000 80X160X150 130X176X210 10 400 500 230,50 5500

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