PharmaVal Professional Services
We provide turnkey solutions; from drafting the User Requirement Specification (URS) right through to Commissioning, Installation Verification and Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Among our core services are the Qualification and Thermal Mapping of warmrooms, coldrooms, cryogenic freezers, fridges, incubators and autoclaves. We provide a wide range of thermal mapping options, for a wide range of unit sizes; from small countertop incubators to large volume mobile warm rooms and cold rooms. PharmaVal have a full suite of the latest industry standard equipment for commissioning and qualification of Controlled Temperature Units (CTU's) and HVAC systems. All Thermal mapping studies are conducted using industry standard CFR Part 11 compliant data logging equipment.
PharmaVal provide professional CQV engineers on contract to pharmaceutical facilities to collaborate as part of their validation teams. Our engineers have a wealth of experience and knowledge within the pharmaceutical industry making their integration to different sites a seamless transition for customers to take full advantage of their expertise and maximise their use.
PharmaVal provide administrative services as customers require it. Our staff can draft protocols for installation, operational studies and qualification studies to the customers’ needs. We cover all aspects of this process including drafting documents and routing through the clients documentation system for approval. We then execute the pre-approved protocols, resolve any deviations as they occur and provide a summary report for the execution. Taking the hassle out of document drafting allowing customers to concentrate on day to day practices while we take care of your additional administrative needs.
PharmaVal have a full suite of the latest industry standard equipment for validation and HVAC design services. We can lease this equipment to customers as required. Our equipment is kept to the highest standards with up to date software. All our equipment isqualified and calibrated to industry standards.
Among the equipment that we offer qualification solutions for are;
Among our core services are the Qualification and Thermal Mapping of warmrooms, coldrooms, cryogenic freezers, fridges, incubators and autoclaves. We provide a wide range of thermal mapping options, for a wide range of unit sizes; from small countertop incubators to large volume mobile warm rooms and cold rooms. PharmaVal have a full suite of the latest industry standard equipment for commissioning and qualification of Controlled Temperature Units (CTU's) and HVAC systems. All Thermal mapping studies are conducted using industry standard CFR Part 11 compliant data logging equipment.
PharmaVal provide professional CQV engineers on contract to pharmaceutical facilities to collaborate as part of their validation teams. Our engineers have a wealth of experience and knowledge within the pharmaceutical industry making their integration to different sites a seamless transition for customers to take full advantage of their expertise and maximise their use.
PharmaVal provide administrative services as customers require it. Our staff can draft protocols for installation, operational studies and qualification studies to the customers’ needs. We cover all aspects of this process including drafting documents and routing through the clients documentation system for approval. We then execute the pre-approved protocols, resolve any deviations as they occur and provide a summary report for the execution. Taking the hassle out of document drafting allowing customers to concentrate on day to day practices while we take care of your additional administrative needs.
PharmaVal have a full suite of the latest industry standard equipment for validation and HVAC design services. We can lease this equipment to customers as required. Our equipment is kept to the highest standards with up to date software. All our equipment isqualified and calibrated to industry standards.
Among the equipment that we offer qualification solutions for are;
We draw up protocols tailored to meet project requirements. We provide thermal mapping solutions, exposure times, pressure checks etc. There is a huge variation in temperature ranges across a range of equipment with specific temperature requirements. We have industry standard equipment to cater for this. Among the equipment we provide services for are listed below;
Fridges/Freezers
Used extensively throughout the industry for the storage of product, test media, lab samples etc where temperature is the critical control parameter. Temperature ranges vary greatly depending on the product or samples being stored.
Incubators
Help create the ideal culturing requirements for cell cultures requiring unique environmental and media formulations and are key pieces of equipment in engineering a cell culture for upstream processing.
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Cold rooms
Used for large scale storage of product, samples etc where temperature is the critical control parameter. Cold rooms allow large quantities of product to be stored at the same temperature in a controlled environment.
Warehouses
Storage of product and materials Pre and Post processing is important. Temperature can be a critical factor of storage.
Cryogenic Freezers
Cryogenic freezing is designed to freeze living objects at -196 Degrees Celsius. It is a process developedtosafely freeze and thaw living objects so they can be revived to the exact condition they were in when they entered the freezing process.
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Autoclaves
Used in the sterilization of components for many operations within the Pharma and healthcare industries.
SIP
STERILIZATION IN PLACE (SIP) Module is a fully automated Sterilization in Place System for Sterilization of Processing vessels in Sterile areas. Used in Pharma facilities in process cycles for vials, sterile solutions, vaccines etc.
Dry Heat Ovens
Dry heat sterilization of an article is one of the earliest forms of sterilization practiced. Dry heat, utilizes hot air that is either free from water vapor, or has very little of it, and where this moisture plays a minimal or no role in the process of sterilization.
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Depyrogenation Tunnels
Depyrogenation tunnels are used in pharmaceutical filling lines to sterilize glass containers before they are aseptically filled. These tunnels use unidirectional hot air at temperatures up to 600° F (350° C) and can be used to sterilize and depyrogenate glass vials, ampoules, and cartridges
Lyophilizers
Lyophilizers are used in pharmaceutical sterilisation processes. It is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.
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