Vindonwestech - Pharmaceutical

Biological & Ultra-Low temperature storage

nospam@example.com (David Cummins) — Thu, 01 Jul 2010 10:50:02 +0000

Specification

Vindon has been manufacturing controlled environment chambers for over 40 years and it is these units, with proven reliability and very accurate control of temperature and humidity, that are used in the Vindonwestech storage suite.

Facility & Support

Purpose built stability storage facility close to all transit links (airports & road networks)
Vindonwestech service professionals on call at all times
Spare running and validated disaster recovery cabinet
Backup generator
24/7/365 facility support & maintenance

Monitoring

In house Eurotherm data logging & monitoring system (NIST Traceable)
Full system redundancy with backup system in house
Data backed up offsite daily
FDA Title 21 CFR part 11 compliant monitoring system.
System validated

Compliance

Over 60 years combined experience within the group
Dedicated QA/QC department within the group
ISO 9001 compliant (est. certification Dec 2010)
Cabinets validated to ICH standards

Sample Management

Detailed reports available
Scheduling system for client pull returns
Full confidentiality of samples at all times. i.e. All projects are labeled with a project and client assigned name

Shipping

Same day or next day sample returns to anywhere in the contiguous USA
All shipments are assigned an individual tracking number
A full complement of temperature controlled shipping packages including -20C and Dry Ice
Data logged transport of samples to monitor compliance
Partnership with global logistics leader

Security

Full alarm system including motion and smoke detectors will monitor the facility environment every second of every day
All access points in the building will have alarm contacts
Closed circuit television monitors the outside of the building for personnel or vehicle activity. Providing a safe and secure environment for all samples
Cabinets physically locked at all times
Cabinets located with an access controlled part of the facility, restricted down to trained authorized staff

All of our Ultra-low chambers are services and validated annually

Vindowestech's Ultra low temperature secure storage chambers are ideal for biological and pharmaceutical products.

The chambers are validated annually with all the documentation being pre-authorised for use prior to the commencement of the validation. The validation and associated documentation are completed by trained Vindonwestech engineers. The completed documentation is checked by another validation engineer before a final check and approval by the Vindon QA department.

Our in-house service engineers service the chambers annually, inline with Vindonwestech's rigorous service procedures.

All of our chambers are continually monitored via our CFR 21 part 11 compliant data acquisition system. The validated data acquisition system will alert our on-call team if any deviations outside the specification limits.

E.g. -80ºC (-5/+7ºC) Any reading above -73ºC or below -85ºC will alert our on-call team to respond to site within two hours - and in the event of a chamber failure, Vindonwestech has spare dedicated and validated chambers to allow for the controlled movement of your product, protecting its integrity at all times.

Click the images below to view our Low temperature & Ultra-low temperature chamber validation traces

-20º Chamber Validation trace

-80º Chamber Validation trace

Photostability

nospam@example.com (David Cummins) — Thu, 01 Jul 2010 10:10:04 +0000

Specification

Facility & Support

Purpose built stability storage facility close to all transit links (airports & road networks)
Vindonwestech service professionals on call at all times
Full spare parts inventory on site for all chambers
Backup generator
24/7/365 facility support & maintenance

Monitoring

In house Eurotherm datalogging & monitoring system (NIST Traceable)
Data backed up offsite daily
FDA Title 21 CFR part 11 compliant monitoring system including logging temp, humidity, entry/exit of chamber
System regularly validated

Compliance

Over 60 years combined experience
Dedicated QA/QC department
ISO 9001 compliant (est. certification Dec 2010)
Full Standard Operating Procedures (SOP’s) – available on request

Sample Management

Detailed reports available
Advanced scheduling system for client pull returns
Full confidentiality of samples. i.e. All projects are labeled with a project and client assigned name

Shipping

Same day or next day sample returns to anywhere in the contiguous USA
All shipments are assigned an individual tracking number
A full complement of temperature controlled shipping packages including dry-ice, ambient & 2ºC to -8ºC dependent on required condition
Datalogged transport of samples to monitor compliance
Partnership with global logistics leader

Security

Full alarm system including motion and smoke detectors will monitor the facility environment every second of every day
All access points in the building will have alarm contacts
Closed circuit television, assisted by monitors outside the building for personnel or vehicle activity
Provides a safe and secure environment for all samples

designed to meet all ICH harmonised tripartite guidelines and validated annually

Vindonwestech has both option 1 and option 2 validated light cabinets which conform to ICH - Q1B

Our photostability cabinets have been designed to meet all ICH Harmonised Tripartite guidelines covering Stability Testing of new drugs, drug products and photostability testing. (Q1B).

The cabinets are validated annually with all the documentation being pre-authorised for use prior to the commencement of the validation. The validation and associated documentation are completed by trained Vindon engineers. The completed documentation is checked by another validation engineer before a final chech and approval by the Vindon QA department.

Our in-house Service Engineers service the cabinets annually, in-line with Vindon's rigorous service procedures. Which includes replacing the calibrated LUX and UVA sensors every two years.

All of our photostability cabinets are connected to our data acquisition system which is CFR21 part 11 compliant. The validated data acquisition system continually monitors the LUX and UVA levels within the cabinet.

Stability Storage Services

nospam@example.com (David Cummins) — Mon, 08 Mar 2010 12:32:26 +0000

Specification

Facility & Support

Purpose built stability storage facility close to all transit links (airports & road networks)
Vindonwestech service professionals on call at all times
Full spare parts inventory on site for all chambers
Backup generator
24/7/365 facility support & maintenance

Monitoring

In house Eurotherm datalogging & monitoring system (NIST Traceable)
Data backed up offsite daily
FDA Title 21 CFR part 11 compliant monitoring system including logging temp, humidity, entry/exit of chamber
System regularly validated

Compliance

Over 60 years combined experience
Dedicated QA/QC department
ISO 9001 compliant (est. certification Dec 2010)
Full Standard Operating Procedures (SOP’s) – available to view on request

Sample Management

Detailed reports available
Advanced scheduling system for client pull returns
Full confidentiality of samples. i.e. All projects are labeled with a project and client assigned name

Shipping

Same day or next day sample returns to anywhere in the contiguous USA
All shipments are assigned an individual tracking number
A full complement of temperature controlled shipping packages including dry-ice, ambient & 2ºC to -8ºC dependent on required condition
Datalogged transport of samples to monitor compliance
Partnership with global logistics leader

Security

Full alarm system including motion and smoke detectors will monitor the facility environment every second of every day
All access points in the building will have alarm contacts
Closed circuit television monitors the the outside of the building for personnel or vehicle activity, providing a safe and secure environment for all samples

Long term testing, retain samples, secondary storage,
storage of quarantine samples,
freeze/thaw testing.

With walk-in rooms and chambers simulating all of the ICH world climatic zone temperatures for long term, intermediate and accelerated testing, Vindonwestech can provide stability storage in the US whatever the size of product.

Our stability storage suite provides environmentally controlled rooms dedicated to the secure storage of pharmaceutical products, clinical trial material, solvents, dry powder inhalers (dpis), pressurised metered dose inhalers (pMDIs), nasal sprays, nebulisers, tablets and capsules - and pharmaceutical bulk chemicals on stability storage.

In addition we have photostability cabinets for testing pharmaceuticals to measure their level of degradation in the presence of ultraviolet and visible light.

Environmentally Controlled Storage Services

nospam@example.com (David Cummins) — Tue, 16 Feb 2010 11:27:05 +0000

Stability Storage Services

Rooms and chambers simulating bespoke and ICH world climatic zone conditions for long term, intermediate and accelerated testing

Stability Storage Services

Low Temperature Storage

Vindonwestech's low-temperature secure storage facility is ideal for high value goods and perishables

Low Temperature Storage

Biological & Ultra-Low Temp. Storage

A storage solution for the preservation of biologics, reagents, and specimens at temperatures down to -80°C.

Biological & Ultra-Low Temperature Storage

more than 20 years of expertise in providing controlled environment storage services to the pharma and biopharm sectors

Vindonwestech's purpose built, Environmentally Controlled Storage facility offers the full range of ICH Climatic Zones.

Employing full-time stability technicians and service & validation engineers - the new Vindonwestech Storage facility is dedicated solely to providing the best service possible to our Pharmaceutical and Biotechnology customers in the US.

Vindonwestech offers stability storage at a wide range of ICH conditions and also provides unique conditions. For long term storage we offer freezers operating at -20°C down to -80ºC.

The Technology that makes us different

nospam@example.com (David Cummins) — Sun, 15 Mar 2009 14:41:34 +0000

Humidity Control

The chambers use TDK ultrasonic transducers to produce humidity. When humidity is needed, a metal plate vibrates creating a focused beam energizing the water molecules just below the water surface A 'cloud' of water droplets then form just at the surface. Air is then taken from the chamber, mixes with the vapor cloud for humidity, and is reintroduced into the chamber.

Benefits include:

Ultrasonic transducers run only when humidity is needed reducing cost of energy
Humidity is generated immediately when needed.
With no heat output from the system, the need for extra cooling is reduced
Humidity generation is terminated immediately when room equilibrates De-humidification option to 15%RH and below is possible with the addition of a desiccant dryer.

Temperature Control

For applications requiring operating temperatures above 10ºC, an indirect refrigeration system is recommended. Unlike a direct system where the refrigerator evaporator is located in the room and runs at sub zero temperatures, our indirect system simply uses water as the coolant passing through a coil located in the chamber. The water is cooled by a refrigeration system, using R134A refrigerant, with the temperature set just below the dew point of the room. This results in less power being used by the heaters and also acts as a balance to provide extra control of the humidity level inside the room.

Benefits include:

No ice up and, therefore, no need for defrost cycles
Close matching of surface temperature to dew point of internal air for greater humidity control
Requires less energy from heater to offset cold air For applications requiring temperatures below +10ºC but above 0ºC, the type of refrigeration system will be selected to suit the particular requirement.

Energy Consumption

With a combination of indirect cooling and ultrasonic transducers for temperature and humidity control, we are able to realize significant savings on energy cost. Our chambers require significantly less energy draw than other chambers available on the market, while maintaining a very stable environment.

Shelving

We use perforated solid stainless steel for all of our shelves to give you a sturdy flat smooth surface and ensure optimum air movement throughout the chamber for the most uniform conditions.

Stability Storage

Vindon chambers and engineering techniques have been honed and perfected over 40 years of industry experience.

The design and manufacture of all chambers is geared towards reduced energy usage and therefore lower cost of ownership. The section of our website contains an explanation of the technologies involved in creating these high quality Stability rooms and cabinets, how they work to keep the tightest tolerances and uniformities, and how they reduce energy costs.

Stability Storage Walk-in Rooms

nospam@example.com (David Cummins) — Sun, 15 Mar 2009 14:40:47 +0000

All Vindon Stability Chambers

Panels	2.4 inches foamed-in-place polyurethane insulation
Internal Coating	Stainless steel (grade 304 or better)
External Coating	Epoxy coated steel
Shelving	Stainless steel (grade 304)
Extras (Included as standard)	• Side access port for validation access • Alarm Systems: • High & low temperature alarm • High & low humidity alarm • Volt free contacts for remote alarm notice

We design and build validatable controlled environment room systems that provide the climactic conditions specified in the ICH Tripartite guidelines, simulating the conditions of all 4 climactic zones for long-term, intermediate and accelerated testing. Our Walk-Ins are completely customizable and offer a circulation technique to ensure the best temperature and humidity uniformity throughout the chamber for optimum storage conditions.

Take a look at the technology that makes us different for more details of humidity controls, temperature controls and energy consumption common to all our Vindon Stability Storage rooms and cabinets

Stability Storage Reach-in Rooms

nospam@example.com (David Cummins) — Sun, 15 Mar 2009 14:39:57 +0000

Reach-In Internal Capacity

1-Door Reach-In	ST-RI1	62 cubic feet
2-Door Reach-In	ST-RI2	113 cubic feet
3-Door Reach-In	ST-RI3	165 cubic feet
4-Door Reach-In	ST-RI4	216 cubic feet

All Vindon Stability Chambers

Panels	2.4 inches foamed-in-place polyurethane insulation
Internal Coating	Stainless steel (grade 304 or better)
External Coating	Epoxy coated steel
Shelving	Stainless steel (grade 304)
Extras (Included as standard)	• Side access port for validation access • Alarm Systems: • High & low temperature alarm • High & low humidity alarm • Volt free contacts for remote alarm notice

Our Reach-In rooms offer the highest capacity storage of any reach-ins on the market with a footprint slightly larger than our cabinets. These chambers offer the same laminar airflow as our cabinets, but allow for much more storage space. Our 4-Door Reach-In offers the same storage capacity as an 8ft. x 8ft room (64 ft2 of floor space) while offering a 13ft x 3ft footprint fitting easily out of the way against a long wall.

Take a look at the technology that makes us different for more details of humidity controls, temperature controls and energy consumption common to all our Vindon Stability Storage rooms and cabinets

Stability Storage Cabinets

nospam@example.com (David Cummins) — Sun, 15 Mar 2009 14:39:25 +0000

Cabinet Internal Capacity

1 Door Cabinet	ST-5600	14 cubic feet
2 Door Cabinet	ST-5799	29.5 cubic feet
2 Door Reach-In	ST-5804	44.5 cubic feet

All Vindon Stability Chambers

Panels	2.4 inches foamed-in-place polyurethane insulation
Internal Coating	Stainless steel (grade 304 or better)
External Coating	Epoxy coated steel
Shelving	Stainless steel (grade 304)
Extras (Included as standard)	• Side access port for validation access • Alarm Systems: • High & low temperature alarm • High & low humidity alarm • Volt free contacts for remote alarm notice

Vindon Stability Storage cabinets are a great solution for small labs needing minimal storage space or simply for small samples at accelerated conditions. Horizontal airflow through the cabinet allows greater packing density without compromising testing conditions. Our cabinets come pre built and constructed ready for use.

Take a look at the technology that makes us different for more details of humidity controls, temperature controls and energy consumption common to all our Vindon Stability Storage rooms and cabinets

Stability Storage Rooms & Cabinets

nospam@example.com (David Cummins) — Sun, 15 Mar 2009 14:31:34 +0000

Stability Storage Walk-in Rooms

Validatable controlled environment Walk-in room systems that provide the climactic conditions specified in the ICH Tripartite guidelines.

Stability Storage Walk-in Rooms

Stability Storage Reach-in Rooms

Our Reach-In rooms offer the highest capacity storage of any reach-ins on the market with a footprint only lightly larger than our cabinets.

Stability Storage Reach-in Rooms

Stability Storage Cabinets

Our cabinets are a great solution for small labs needing minimal storage space or simply for small samples at accelerated conditions.

Stability Storage Cabinets

Total humidity control is key and our design specification will determine the operating humidity range

Vindon Stability Storage Rooms and Cabinets are manufactured using engineering techniques that have been honed and perfected in over 40 years of industry experience.

The design and manufacture of all chambers is geared towards reduced energy usage and therefore lower cost of ownership.

Take a look at the technology that makes us different