Steam-In-Place (SIP) strategy

One of the most common methods for creating a sterile bioprocessing environment is the use of heat in the form of steam to eliminate unwanted organisms. Steam-In-Place (SIP) is a good sterilization method and involves sterilizing by means of steam the interior of pipes, vessels, process equipment, and associated fittings, without disassembly.
Steam-in-Place (SIP) can be a critical element in any startup and commissioning project. However, the full range of SIP strategies are not always thoroughly understood, and thus many manufacturers miss important elements of these techniques.
To know more about the application of SIP, about • Bioburden reduction• Saturated steam conditions: Temperature/pressure relationship• Autoclaves, vessels, filters and transfer lines• Empty- and full-vessel SIP• Proper use of Tempilstik®
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Effective Steam-in-Place Strategies to Consider before Qualifying a Facility

How Green Is Your Plant?

While the automotive, chemical, cosmetic industries have made strides in reducing their carbon impact, the pharmaceutical and biopharmaceutical industries have lagged behind. It has been estimated that organizations can reduce their Carbon Footprints by as much as 20 per cent through the implementation of lean processes. By applying operational excellence techniques, a strategy can be developed to assist pharmaceutical manufacturing and supply chain operations to achieve more “Green Operations”. By adopting a focused practice to inventory wastewater, hazardous and solid waste streams, and energy consumption a facility’s carbon footprint can be determined. Efforts can them be focused on key waste generating areas such as gowning, facility cleaning, equipment cleaning and process operations. Not only will these efforts reduce the environmental impact of manufacturing operations, but they will ultimately reduce costs. Risk management and Quality-by-Design approaches will enable firms to better understand cleaning cycles, optimize them and reduce water, chemical, time and energy requirements. More efficient cleaning cycles result lower these resource demands and reduce the Carbon Footprint of these waste generating operations.Such strategies can help manufacturing achieve “Green Operations” in the face of mounting pressure for more environmentally friendly corporate citizenship drug manufacturing costs.

You can attaend this webinar to know how to develop a strategy for it
How Green Is Your Plant? – Determining the Carbon Footprint of Your Operations

Records covered in 21 CFR part 11 for clinical data

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Residual Solvent Analysis According to USP <467>

•“ Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used in the manufacture of drug substances and impurities or excipients, or in the preparation of drug products
•Residual solvents refers to the amount not removed during the purification of the product
•Residual solvents are one of the three main types of impurities in pharmaceutical articles (other two: organic and inorganic impurities)
•Residual solvents need to be controlled (ICH, USP, EP) and control is enforced (e.g., FDA)
USP Requirements

•All drug substances, excipients, and drug products (dosage forms) are subject to relevant control of residual solvents, even when no test is specified in the individual monograph
•Acceptable limits depend on solvent classification(toxicity, consistent with risk based approach)
•USP incorporates ICH Q3C classification and evaluation system and EP procedures
•Requirements aligned with ICH Q3C
•Testing is to be performed only for solvents “likely to be present”
–Used or produced in the final manufacturing step
–Used in previous steps and not removed by validated procedure
–Important for suppliers to disclose solvents (and manufacturing process)
•Limits for acceptable concentrations listed in the chapter are for drug products NOT for its components
•Quantitative or limit tests
•The concentration in the drug product may be
–Calculated from the contributions of components
–Determined experimentally; mandatory if:
–Solvents are used in its manufacture
–Cumulative calculation exceeds limits
•Manufacturers of drug products may rely on data provided by the suppliers of components
•The procedures described in this general chapter are to be applied whenever possible.Otherwise other methods can be used
Main changes to previous USP revision

•Title change: From “Organic Volatile Impurities (OVI)” to residual solvents
•Largely refer to ICH QC3 terminology, solvent categories and acceptance criteria
•Widely harmonized with EP
•Individual test procedures in Monographs replaced by general chapter <467>
•Finished product testing may not be necessary (testing of APIs and excipents may be enough)