Batch S88 Standard Overview

BATCH Standard

Standards exist to facilitate understanding and communication between the people involved. They help optimize revenue and you don't have to start from scratch for every new project. ANSI/ISA S88 is no exception. Although the benefits of S88 may be obvious to some, they are not necessarily as obvious to the decision makers.

S88 defines hierarchical recipe management and process segmentation frameworks, which separate products from the processes that make them. The standard enables re-use and flexibility of equipment and software and provides a structure for coordinating and integrating recipe-related information across the traditional ERP, MES and control domains.

In order to justify the use of S88, it is important to link its technical benefits to the business benefits of such an implementation.

S88 isolates recipes from equipment. When the software (S88-compliant or otherwise) that defines a product (recipe procedure) and the software to run equipment (phase logic) are in the same device (such as a PLC or DCS), the two different sets of code eventually become indistinguishable and, in some cases, inseparable. This makes recipe and equipment control difficult, if not impossible, to maintain. Every additional ingredient and process improvement can lead to lengthy and error-prone software changes. Documenting and validating such a system is also extremely difficult, and doubly so if not S88-compliant.

If recipes are kept separate from equipment control, however, the manufacturing process is more flexible and can provide significant advantages: Automation engineers can design control software based on the full capabilities and performance of the equipment rather than on the requirements of the product. Similarly, scientists, process engineers or lead operators who create the recipes can now easily create and edit them.

Separating products from the process that makes them raises the bar on plant flexibility. Equipment that may currently be constrained to one or a limited number of products may be able to accommodate more, improving overall equipment effectiveness (OEE) metric - a metric that has become the crucial link between the financial and operational performance of production assets.

Batch S88.01 ANSI/ISA Standard

Pharmaceutical Validation

Pharmaceutical Validation is the implementation of a quality system approved by the FDA.

It is designed to ensure that every part of a pharmaceutical installation meets the standards during every stage of its lifecycle (design, construction, startup, production, maintenance and decomissioning). Keywords are "Good practices" and "Traceability". It is a very large field and some parts of it may not require much technical knowledge. However, if you have to prove that a certain program in a controller will act in certain ways, it may be useful to at least know how these things work in order to design a testing procedure to prove (validate) that this is true.

Pharmaceutical Validation is always teamwork. Mechanical, electrical, automation, control, process and software engineers each have to assist the validation officer with all the necessary documentation and testing. The only person that is not really a technical specialist is the validation officer. However to be successful, he must have a broad knowledge of technical stuff without real specialized knowledge in a specific field. His main job task is the interfacing between the technical staff and the FDA and therefore he is responsible for the final FDA approval of the entire project.

Check out the 21-CFR-Part 11 regulations (Electronic Records, Electronic Signatures), which has become the standard for the pharmaceutical industry.

>>> What is 21-CFR-Part 11?

ANSI/ISA S88 design concepts make validation easier. A modular S88 design will allow one to validate (and revalidate) procedures and equipment separately. With well-written equipment phases, for example, once Phase A is validated, modifying other phases will not upset Phase A's validated state.

Also, validating a recipe procedure is easier once the phases are validated. Since recipe procedure code is decoupled from equipment phase code, the need to revalidate a recipe procedure does not necessarily require that all phases be revalidated. Theoretically, one can validate new additions to a process or revalidate changes to a process faster. Moreover, the S88 modular design approach helps minimize the risk that a change to one part of the process will affect another. Validating new additions to a process or revalidating changes to a process faster, results in the product making it to the market quicker.

IQ / OQ / PQ

Installation Qualification, Operational Qualification, and Performance Verification of equipment and instruments is a vital link in the quality chain.  One of the major areas of focus for both FDA (or any other regulatory body) and client audits.  All equipment and instruments must meet manufacturer's or preset standards for operation and performance.

Installation Qualification does not just apply to a brand new piece of equipment or instrument.  A used instrument or piece of equipment that is new to the site must also undergo installation qualification.  Movement of equipment or instruments requires re-Installation Qualification to ensure proper operation.  Many new pieces of equipment and instruments include either instructions for IQ or options for the manufacturer to perform IQ for you.

Operation Qualification and Performance Verification must be perform at least annually for every piece of equipment or instrument.  Most manufacturers have provisions for performing these services, at a cost.  This can be confusing, time consuming and costly to allow the manufacturer to perform.

Performance Verification is also necessary for movement of equipment and instruments to prove the operation prior to and after the movement of said equipment and instruments.