connected about Prism Plates

About Us


Company Profile

Ready Prepared Culture Media * FDA 21 CFR part 11 compliant  * Harmonized USP/EP/JP * ISO 9001 * ISO/IEC 17025 * ISO 11133

Prism plates was founded in April 2019 and has manufactured 'custom-made' Ready Prepared Culture Media and Animal Blood Products to the highest possible standard ever since. 

 

With over 15 years of Microbiology Experience, we serve the Clinical-, Pharmaceutical-, Biotechnology-, Cosmetic-, Water-,  Veterinarian-, Food- and Environmental Microbiology Testing- Laboratories.

Our state -of -the- art Manufacturing facility located in holi city of Haridwar India.

Every new enterprise has a fundamental purpose. Ours is driven by our passion for science and commitment to helping you accelerate innovation.

From discovery to delivery, we are a trusted global partner to customers and suppliers in the life sciences and advanced technologies industries.

By providing superior product and service solutions, we catalyze innovation and empower the success of our customers.

Product range

We supply all media according to the Harmonized USP/EP/JP to perform Sterility and Microbiological Tests.

 

 

ISO 17025:2005 Accreditation

Prism plates is proud to announce that its QC laboratory, performing the quality control of their Ready Prepared Culture media, is accredited for an additional 3 years period (2019 untill 2022) by the Dutch Council of Accreditation in accordance with the recognised International Standard ISO/IEC 17025:2005 ‘General Requirements for the competence of testing and calibration laboratories’. The accredited methodology conforms to ISO 11133:2014.

 

 

 

ISO 9001

It is the policy of Prism Plates to achieve the highest degree of product quality, ensuring that processes and services are continuously improved and in line with international standards and customer requirements. The company's total commitment to quality and performance was reflected in 2019, when Prism Plates successfully achieved ISO 9001 accreditation. Furthermore, partly due to many external audits being regularly undertaken at our facility, our quality management systems is adapted to GMP.

 

ISO/IEC 17025 - ISO 11133

Our QC lab, performing the quality control of all batches Ready Prepared Culture Media, is accredited by the ISO of Accreditation in accordance with the recognised International Standard ISO/IEC 17025 'General Requirements for the competence of testing and calibration laboratories'.  The accredited methodology is conform ISO 11133 Click here for the ISO/IEC 17025 declaration.

 

Harmonized USP/EP/JP

Our Ready Prepared Culture Media meet the harmonized USP/EP/JP formulations and performance criteria*.

Quality Control

Extensive quality control for sterility and bacterial growth parameters among others are carried out by our laboratory. Every batch of media is tested to international standards or to customer specifications. Organism challenges and sterility testing can be tailored to duplicate your present in-house methods, saving the customer a lot of time; less quality control to be performed by the customer.

Quality Control Certificates can be downloaded using a login password.

 

FDA compliant

Our facility- and environmental-monitoring systems (including microbiological- & partical measurement) are ‘FDA 21 CFR Part 11 compliant’.

 

State-of-the-art production facility

The new ultramodern production facility in Haridwar, opened in 2019, is designed and equipped to meet pharmaceutical regulations, for Ready Prepared Culture Media. For the production of Ready Prepared Culture Media we use some of the most advanced equipment available, including: magnetic stirred media preparation vessels, water cascade autoclaves, multi-lane pneumatic petri dish filling machines, 2-D-datamatrix barcodes and more. We produce in cleanrooms class 5 to 8 (conform ISO15644-1).

 

  • Audit report quotes
  • ''The quality documentation system of Prism plates is meeting the current ISO and GMP standards'.
  • 'A strongly developed computerized system controls orders, the process, delivery to customers as well as quality and traceability of microbiological media'.
  • 'Hygiene, housekeeping, storage space and routing were seen as very impressive, Prism plates clearly demonstrated to have quality high in their standard'.
  • 'The routing of raw materials to end products is very well organized'.
  • 'All critical process steps are automatically monitored and controlled'.
  • 'Equipment is validated and maintained on a regular basis and records are kept'.
  • 'Traceability is assured. Traceability is possible up-stream as well as down-stream'.
  • 'Every raw material and end products including process runs can be traced to the customer'.
  • 'The appropriate quality, scientific and technical knowledge of the participants was experienced during the audit'.
  • 'The plant was found to be well designed for its purpose'.
  • 'The impression of the employees was motivated and alert personnel who were very well trained for their jobs'.
  • 'The standard operating procedures reviewed during the tour were impressive and detailed the processes effectively, including flow diagrams were appropiate'.
  • 'The facility was extremely well organised and maintained'.
  • 'The facility was well designed, orderly and clean'.
  • 'Based on our audit, the Excellence status has been given to Prism plates'.
  • The manufacturing areas were 'inbuilt' design and process flowed well'.
  • 'The auditors concluded that the quality of the products manufactured by Prism plates is assured by the procedures and the quality system in place'.
  • 'The audit team can confirm that Prism plates complies with our standards for GMP suppliers'.
  • 'The audit gave an impression of a company that has a very good understanding of the pharmaceutical industry and our requirements.'
  • 'The auditor observed that Prism plates premise is a state of the art manufacturing facility'.
  • 'Both facilities and Quality Management System were found to be impressive and very well managed'.
  • 'Prism plates maintains the documentation and overall control to a very high standard'.
  • 'Prism plates has very nice facilities which are at a standard similar to pharmaceutical production facilities'.
  • 'Execution of the audit activities was handled well: good knowledge of processes was proven throughout the orginazation and documentation was shown in a timely matter.'
  • 'Prism plates is a well-orginazed company who wants to please the client and is searching with the client for the best solution.'
  • 'Prism plates company and production area's are well organized and clean.'
  • 'The facilities are generally well maintained, clean and tidy.'

 

 

Corporate Social Responsibility

Prism plates takes Corporate Social Responsibility seriously. We use only environmentally friendly energy, green power and green gas. Green power is generated by renewable sources such as wind, solar, biomass and hydropower.Our CO2 emissions are fully compensated by planting and maintaining forests.

An energy scan was performed by an external agency, in accordance with the NEN-EN 16001 Energy Management Standard. Furthermore our environmental outputs are continuously monitored using our fully automated web-based Energy Management System.

With respect to CSR we take our responsibility!

We are a leader in the manufacture of classic and custom media. We provide products manufactured to international standards or your specifications using your formulation, fill volume and configuration. PRISM PLATES is capable of accommodating your unusual plate, tube, bottle or bag configurations. Organism challenges and sterility testing can be tailored to duplicate your present in-house methods.

Equipment
In our purpose built facility we have a wide variety of modern equipment, validated in accordance with international standards/guidelines. Our autoclaves are not just ordinary steam autoclaves, but they are specially designed; giving us reduced heating up and cooling down time; facilitating in the correct treatment of media, "not over-cooking media" as is sometimes the case in certain circumstances.

Quality Control
Every batch is rigorously tested to meet performance criteria prior to reaching the laboratory bench top. Quality control testing can be designed to use your specific requirements too. 
Quality Control sheets will provide documented testing results and can be downloaded using a login password.

ISO 9001:2008 * ISO/IEC 17025:2005 * ISO 11133:2014 * Harmonized USP/EP/JP * FDA 21 CFR part 11 compliant

Pharmaceutical product range.
We supply all media according to the Harmonized USP/EP/JP to perform Sterility and Microbiological Tests.