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Single-Use NewsLet t er s

July 2014

This periodic newsletter serves as a central resource for information and updates on the

exploding role of Single-Use Technologies in the World of Bioprocess Science and includes

regular contributions from the following important “lettered” sources (in alphabetical order):

ASME-BPE (American Society of Mechanical Engineers-BioProcessing Equipment), ASTM INTERNATIONAL, BPOG (BioPhorum Operations Group), BPSA (Bio-Process Systems Alliance), DECHEMA (Gesellschaft für Chemische Technik

und Biotechnologie/Society for Chemical Engineering and Biotechnology), ELSIE (The Extractables and Leachables Safety Information Exchange), PDA (Parenteral Drug Association), PQRI (Product Quality Research Institute),

SUTAP (Single-Use Technology Assessment Program), and USP (U.S. Pharmacopeial Convention) [See Page 4 for a brief description of each]

SOMEONE STOOD UP!

The summer of 2016 has been a busy and encouraging time for

those invested in the advancement of Single-Use Technologies

(SUT). Ever since the introduction of SUT upended the stainless

steel paradigm, the interactions between manufactures and end

users have increased exponentially. Disposable technology usage

has necessitated an enormous shift in vendor interactions mostly

because end users consume so many more components—so much

more often—than when durable stainless steel was the only act in

town.

Organizations, many of whom contribute to this newsletter, have

made some strides in improving the alignment and interactions

between SU suppliers and their end users. The progression from

chaos to a game plan is beginning to occur and one organization

stood up this summer to lay out a tangible direction with a timeline.

Their challenge to all of us is: “By April 2021, to get disposables

knowledge and application equivalent or better to that of

stainless steel today (2016).”

At the BPSA International Single-Use Summit in July, members

from BPOG’s disposables work stream for standardization and

guidelines put forth a 5 year plan for the disposables community;

creating an opportunity to give the “Alphabet Soup” members some

much needed direction from BPOG end users. With starting points

stretching to the year 2020, this broad timeline (shown on Page 2)

serves as a helpful graphic for laying out a plan for how to approach

the alignment of SUT standards and best practices. It highlights the

importance of supply chain transparency by breaking down and

tackling the many facets of the supplier/end user relationship from

the well-known (e.g., Change Notification efforts and User

Requirements) to the as yet unfamiliar (e.g., Knowledge

Management and Equivalency).

Transparency must work in tandem with alignment and the sharing

of information, expectations, and even jargon. The fact that some

still consider leachables and extractables interchangeable terms is

a blatant example of why a milestone timeline like this is such a

valuable and necessary tool. If we are all on the same page, we can

turn it at the same time and continue to make purposeful progress

together. ⃞

USP 661.3 AND THE PULL OF COMPENDIA

Another stand-out at the BPSA summit was Desmond Hunt’s

presentation on USP <661.3> (Plastic Components and Systems

Used to Manufacture Drug Products). USP is bringing their history

with plastics from medical device and packaging systems

(<661.1>, materials of construction; <661.2>, packaging systems;

and <1661>, risk evaluation) into the discussion. Their focus is on

safety, material-derived foreign impurities, component or system-

derived foreign impurities and tests which can help characterize

(but not necessarily qualify) the plastics comprising these

impurities (see bottom graphic on Page 2).

Through this approach, USP has come up with a way to look at a

standard extraction protocol for a baseline of extractables—and

they built upon themselves to get there. One key thing to note is

that it can always be expanded when warranted, but USP has given

reasons why this baseline adds value to every situation by “aiming

for the middle”. (continued on Page 2)

September 2016

Single-Use NewsL-e-t-t-e-r-s

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Single-Use News

September 2016

L-e-t-t-e-r-s

In the first draft of this document, currently under review, the USP

recognizes three solvents: ethanol-water mix, basic extraction pH

10 and acid extraction pH 3. In contrast to BPOG’s extractables

protocol, USP does not think there is a scientific rationale for

including water only, NaCl and poloy-sorbate as recognized

extraction solvents. They took a pragmatic approach from the

knowledge base of their team claiming, “…additional extraction

solvent should provide information in addition to the info provided

by the adopted solvents AND be analytically expedient.”

It is perceived that compendia organizations such as USP have

more pull than standards organizations (ASTM, ASME) due to

their direct regulatory reference, and even more pull than

guidelines organizations (BPOG, BPSA). However, standards and

guideline organizations can be more international in scope. Thus

all organizations have value. The challenge is to get these

organizations to cooperate, which is why this newsletter was

started. Through collaborate efforts and proven successes, we have

become more comfortable with the work of the various

organization, and the idea of sharing ideas and information. ⃞

Draft of BPOG’s Disposables 5-Year Plan

(Note: timeline shows approximate start points – not durations)

Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2107 Q3 2017 Q4 2017 2018 2019 2020 2021

Extractabless

Leachables

User Requirements

Change Notification

Room

Classification

C of A

(without testing)

Single Use

Auditing Guide

Labelling

Data Packages

Validation,

Sterilization etc..

Risk

Assessment Re-validation

frequency by

type

Base line

Qualification /

Validation

Standardization

(dim / materials /

functionality)

Standard

Engineering /

Design practices

SUS

Perry’s

Handbook

Equivalency

Supply Base

Benchmark

Survey

Supply Chain

Transparency L1, L2..

Supply Chain

Risk Mitigation

strategy

Data Sharing Knowledge

Management

Training

TCO Models

The Essence of

the USP

Strategy for

Plastics

(graphic from D. Hunt’s presentation )

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Single-Use News

September 2016

L-e-t-t-e-r-s

EXTRACTABLES & LEACHABLES For important information, check out ELSIE’s new article published in the

November issue of Regulatory Toxicology & Pharmacology Journal. The

article is entitled Assessing Safety of Extractables from Materials and

Leachables in Pharmaceuticals and Biologics – Current Challenges and

Approaches. For more information, click HERE.

PARTICULATES SUTAP is continuing their work along with ASTM.

SYSTEM INTEGRITY BPSA and ASME are currently working together on their system integrity

report. This will be presented at the ASME-BPE meeting in Providence, RI

the week of September 12th.

CHANGE NOTIFICATION BPOG and BPSA continue their joint project involving a standard Change

Notification Form and the supporting procedure. A final version is expected

soon. This team is also working on a related white paper which is expected

to be released by the end of 2016. This white paper will be accompanied by

examples of changes and explanations of how the new Change Notification

Form should be used to document those changes.

SUPPLY CHAIN

Following a meeting last March to clarify the scope of the project, BPSA and

BPOG are collaborating to develop a universal template for User

Requirements. They are currently working on a guidance document to support

this template and help improve the sharing of information. Sterilization

Validation and Physical Functional Properties are the first two attributes to be

explored in this joint effort.

DESIGN VERIFICATION There has been a lot of talk on this topic. An ISPE document is considering

many aspects and there was a fair amount of discussion on this at the recent

DECHEMA 2016 biopharm and SUT conference. Stay tuned!

OTHER SINGLE-USE UPDATES

ASTM’s E55 Committee will be host a meeting on the Manufacture of

Pharmaceutical and Biopharmaceutical Products on October 11-13. Day 1 will

feature a joint workshop with the FDA on Current and Future Standards

Activities within Pharmaceutical and Biopharmaceutical Manufacturing.

Presumably, the workshop, which will take place at the FDA’s facility in Silver

Springs, MD, should include discussions on Single-Use Technologies. □

ASME BPE ASTM BPOG BPSA DECHEMA ELSIE PDA PQRI SUTAP USP

Extractables X X X X X X X X X X

Leachables X X X X X X X X X

Particulate X X X X X X X

System Integrity X X X X X X X

Connectors X X X

Supply Chain X X X X X X

Design Verification X X X X X X

Biocompatability X X X

A Summary

of Current

SUT

UPCOMING SINGLE-USE EVENTS

ASME BPE–PROVIDENCE, RI September 12-15, 2016

BPSA European Summit–BARCELONA, SPAIN September 26-28, 2016

Bioprocess Int’l Biotech Week Conference–BOSTON, MA October 4-7, 2016 Town Hall on the Main Stage October 6th, 2:30 pm to 3:45 pm

ELSIE Materials Workshop-DARMSTADT, GERMANY October 20, 2016 Registration is now open! To register lick HERE

ASTM E55/FDA Meeting on Manufacture of Pharmaceutical and Biopharmaceutical Products – FDA White Oaks Campus– SILVER SPRINGS, MD October 11-13, 2016 Registration is now open! Visit ASTM.org or click HERE.

CURRENT TABLE OF SINGLE-USE ACTIVITIES

FOR FURTHER INFORMATION ON THIS TABLE, PLEASE VISIT www.bioprocessinstitute.com/single-use-news

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Single-Use News

September 2016

L-e-t-t-e-r-s

A brief description of the major organizations involved in Single-Use Technologies can be found below in alphabetical order. Please visit their websites for a broader description of their industry involvement, a list of their upcoming meetings and events, and membership information.

ASME-BPE (American Society of Mechanical Engineers - BioProcessing Equipment Standard) www.asme.org

The ASME-BPE Standard is intended for design, materials, construction, inspection, and testing of vessels, piping and related accessories such

as pumps, valves, and fittings for use in the biopharmaceutical industry. This standard (www.asme.org/products/codes-standards/bpe-2012-

bioprocessing-equipment ) also provides requirements for Single-Use Systems and components.

ASTM International www.astm.org

ASTM International develops international voluntary consensus standards similar to the ASME BPE. Twelve thousand ASTM standards are

used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM

International includes more than 30,000 of the world’s top technical experts and business professionals, representing 150 countries. Working in

an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications,

guides, and practices which support industries and governments worldwide. (Contact Travis Murdock: TMurdock@astm.org)

BPOG (BioPhorum Operations Group) www.biophorum.com

BPOG consists of experts from biopharma drug substance operations who meet and work together at fact-to-face meetings in the U.S. and

Europe on a regular basis. They have 32 member companies with over 1,400 participating representatives. BPOG has established best practices

on a wide range of quality, engineering and organizational topics central to the challenge of mastering a biotech drug substance operations.

BPOG is made of up exclusively of end users.

BPSA (Bio-Process Systems Alliance) www.bpsalliance.org

The BPSA is an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of Single-Use

manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices,

development of consensus guides and business-to-business networking opportunities among its member company employees.

DECHEMA (Gesellschaft für Chemische Technik und Biotechnologie/Society for Chemical Engineering and Biotechnology)

www.dechema.de/en/

DECHEMA is the expert network for chemical engineering and biotechnology in Germany. As a non-profit professional society we represent

these fields in science, industry, politics and the general public. DECHEMA promotes scientific and technical exchange among experts from

different disciplines, organisations and generations. We consolidate the know-how of over 5,800 individual and sustaining members.

ELSIE (The Extractables and Leachables Safety Information Exchange) www.elsiedata.org

ELSIE was formed in 2007 with the core objective of establishing a comprehensive database which provides a jointly-developed and credible

source of safety information on extractables and leachables as well as extraction profiles and standardized study protocols for a range of

materials commonly used in pharmaceutical, biological and device applications and processes (e.g. container closure systems, devices,

manufacturing/processing, etc.).

PDA (Parenteral Drug Association) www.pda.org

PDA is the worldwide leading provider of science, technology and regulatory information and education for the pharmaceutical and

biopharmaceutical industries. Founded in 1946 as a nonprofit organization, PDA now has over 9,500 members worldwide. Using their expertise,

these members are committed to developing scientifically sound technical information for practical uses in order to advance science and its

regulations.

PQRI (Product Quality Research Institute) www.pqri.org

PQRI is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that

advances drug product quality and development. PQRI provides a unique forum to focus critical thinking, conduct research, exchange

information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard setting organizations.

SUTAP (Single-Use Technology Assessment Program) www.sutap.org

SUTAP prepares and maintains documents to be approved within ASTM framework. SUTAP is a not-for-profit organization which supports

building a holistic framework of standards simplifying the development and use of SUT for suppliers and end-users by fostering a transparent and

independent approach. SUTAP enables an efficient collaborate team whose work benefits the entire SU industry.

USP (U.S. Pharmacopeial Convention) www.usp.org

The USP is a scientific nonprofit organization that sets standards for the quality, purity, strength, and identity of medicines, food ingredients,

and supplements. USP’s drug standards are enforceable in the United States by the Food and Drug Administration (FDA). These standards are

also used in more than 140 other countries.

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