SIP (Sterilization-in-place) Systems sterilize mobile systems that normally do not have the in-situ CLEANING WITHOUT VISUAL DISTORTION sterilization facility SIP system (Sterilization - in - Place] caters to mobile vessels that normally do not have the complete in-situ sterilization facility, unlike fixed equipment that come integrated with sterilization capability.
All control valves required for sterilization are in built into the system. By connecting the mobile vessels to the system, complete sterilization including vacuum break can be achieved. Further the system comes with all the data related to sterilization, which is essential for records and quality assurance.
BIOZEEN'S SIP system offers the following advantages:
• Skid mounted
• Corrosion resistant body and trim
• Self-draining design
• Material of construction SS 316L
• Sanitary process connections BIOZEEN also manufactures integrated docking station for CIP and SIP functions.

Filtration System play a vital role in Biologics & Biopharmaceutical industry.
Their application range varies from pilot scale to full-scale production. Some of the applications in a Biopharmaceutical industry include:
• Vaccine and conjugate concentration
• Recovery of antibodies or recombinant proteins
• Fractionation of protein mixtures
• Clarification of fermentation broths
• Cell broth clarification, concentration
•• Blood plasma fractionation and purification

Our design features for Microfiltration Ultrafiltration and Hollow Fiber Filtration System provide you the following advantages:
• Skid mounted, Space conserving, Easy maintenance
• Fixed/Mobile, with or without vessel
• Automated flux measurement to check cleanability
• In-situ sterilizable with or without cassette
• Optimized stabilization time
• Provision for online membrane integrity test
• Minimal hold up volume and Maximum product recovery
• Cassette holders offered to suit different membrane manufacturers
• Automated trans membrane pressure maintenance
 • PLC control system with HMI or SCADA .

Batch Bioinactivation System
• Flexible range
• Skid-mounted
• Agitator (Top/Bottom Mounted)
• Configuration to suit space restrictions
• Design conforms to ASME BPE and GAMP 5 guidelines
• Material of construction - SS 304
• Internal finish Ra<=0.8
• Designed for easy access during operation and routine maintenance
• PLC control system with SCADA
• Configurable control loops
• 100% redundancy for safety

Continuous Bioinactivation System
• Demonstrates up-to 62% Energy Efficiency as compared to a conventional model
• Completes a cycle in one-fourth the time as compared to a conventional model Processes large volumes in a short span of time Is Customized to User requirement
• Realizes a shorter payback period, achieved through Efficient Utility & Energy Utilization Offers Reduced Space Utilization, Reduced man hours and increased Productivity Adheres to ASME BPE and GAMP 5 design guidelines Offers specifications as:
• Material of construction - SS 304
• Internal finish Ra <= 0.8
• PLC control system with SCADA
• Configurable control loops
• Is Designed for easy access during operation and routine maintenance
 • Has 100% redundancy for safety .

Automation Technology enables monitoring, recording, analyzing and controlling of entire plant operations (ranging from the equipment and Human Machine Interface (HMI), MES levels, right up to interfacing with Enterprise Resource Planning (ERP) systems) from a single work station to ensure ease in batch control, assured batch reproducibility and audit compliance.
Our Automation Team at BiOZEEN ensures user friendly operations which are 21 CFR Part 11 ready, in the highly challenging Pharmaceutical & Biopharmaceutical production space.
Our capabilities include:
• Seamless automation & Integration of:
• Multiple unit operations: fermentation, Cleaning in Place, Sterilization in Place, chromatography etc.
• Multiple processes: upstream, downstream and fill & finish
• 3rd party integration : seamless integration of equipment from multiple vendors for multiple unit operations
• Retrofit
• Upgradation of systems .

The filter validation services offered by BiOZEEN include:

• Filtration Train Optimization Study: to assess the series of filter devices including pre-filtration and sterile filtration combination, with an objective to ensure an optimized filtration train capable of providing maximum throughput of the final sterile product without interference between batches.

• Compatibility Study:
plays a pivotal role in submissions pertaining to a new product market authorization and in formulation experiments relevant to changes in product. It is essential to thoroughly assess the chemical compatibility of the product contact components with all equipment, filter devices and materials used in the pharmaceutical manufacturing process, in order to avoid delays in the product development process and deviations that could compromise the quality of the end product. Filter integrity is evaluated post exposure to process fluid at process conditions, as well as pre-determined worst case conditions that include; simulated filter sterilization conditions (for devices), process fluid contact time and process temperature - to determine that the pore size remains unaffected. This is essential preliminary indication to reinforce the choice of the membranes to be used in the filtration train.

• Product based Integrity Study:
Integrity of the filter is its Quality attribute. Sterilizing grade filters require to be tested to assure its integrity pre- and post-filtration process.Integrity values for the test filter are obtained by subjecting it to real life situations - cleaning & sterilization-inplace, followed by integrity testing under normal manufacturing conditions before establishing product wet integrity values. BIOZEEN specialists also perform drug product based integrity testing on filters to establish product integrity ratio values & product bubble point ratio also.

• Bacterial Retention Study:
Validation of a sterilizing filtration process is critical since it is impossible with currently available technology to measure the sterility of each filled container; therefore, sterility assurance of the filtered product must be achieved through validation of the filtration process, hence proving that sterile filtrate is generated.As a part of this study, the filter is challenged with Brevundimonas diminuta (ATCC 19146) under process conditions and demonstrated by testing to produce a sterile filtrate. The size of B.diminuta is critical for determining the retention characteristics of membrane filters. At BIOZEEN the bacterial retention study is performed by trained microbiologists who keep the size of the challenge organism to the minimum and as a mono-dispersed suspension This creates the worst case challenge condition to establish the retention capabilities of a SGF which can be correlated to the product base integrity values.

• Extractable & Leachable Study:
The primary function of filter devices is to remove unwanted contaminants from pharmaceutical products. An ideal filtration device is non-interactive; it does not adsorb any active ingredients from the drug, nor impart extractable into the drug product. At BIOZEEN we to test the filtration device for its retention characteristics, non-interactive ability and safety under minimum and maximum operating conditions. Protein/Preservative Binding Study: Adsorption is a mechanism, which causes the product to bind to the filter membrane; ideally, a filter membrane should not adsorb formula components. Adsorptive filter materials include, membrane, hardware & support materials. Adsorption tests are performed at small scale & confirmed at large scale to ensure product composition & concentration is not affected by such phenomenon taking into consideration factors such as flow rate, product concentration, contact time, preservative concentration, temperature & pH that can affect the level of adsorption.