Barrier Isolat or URS Urs

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USER REQUIREMENTS SPECIFICATION

Barrier Isolator and HVAC System

Doc ID: Barrier Isolator_US_! November 26, 2002

EQUIREMENTS TEMPLATE USER R R EQUIREMENTS for a BARRIER ISOLATOR ISOLATOR AND !A !AC S"STEM

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RE!ISION ISTOR" Rev#

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RE!ISION ISTOR" Rev#

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TABLE OF CONTENTS #0

INTROD INTRODUCT UCTION ION####### ############## ############## ############# ############# ############## ############## ############# ############# ############## ########################### ################################-

2#0

O!ER! O!ER!IE.## IE.######### ############## ############## ############# ############# ############## ############# ############# ############## ############## ############# ############# ############## #################### ###############-

/#0 OPERA OPERATI TIONA ONAL L REQUIR REQUIREME EMENTS# NTS####### ############# ############## ############# ############# ############## ########################### ######################6 ##6 /# CAPACIT"555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555+ /#2 PROCESS R EQUIREMENTS EQUIREMENTS 5555555555555555555555555555555555555555555555555555555555555555555555555555555+ /#/ PROCESS CONTROL55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555+ /# FUNCTIONS 55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555557 /#DATA ATA AND SECURIT"5555555555555555555555555555555555555555555555555555555555555555555555555555555555555558 /#6 EN!IRONMENT 5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555511 #0 CONSTR CONSTRAIN AINTS## TS######### ############## ############# ############# ############## ############# ############# ############## ############## #################### ################################ ################### # MILESTONES AND TIMELINES5555555555555555555555555555555555555555555555555555555555555555555555514 #2 EQUIPMENT CONSTRAINTS 5555555555555555555555555555555555555555555555555555555555555555555555555551, #/ COMPATIBILIT" AND SUPPORT5555555555555555555555555555555555555555555555555555555555555555555551, # A!AILABILIT" 55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555517 #PROCEDURAL CONSTRAINTS 555555555555555555555555555555555555555555555555555555555555555555555555517 #6 MAINTENANCE 5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518 -#0 LIFE1C LIFE1C"CL "CLE#### E########## ############# ############## ############## ############# ############# ############## ############## ############# ############# ############## ############# ############# ################ ######### -# DE!ELOPMENT5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518 -#2 TESTIN3555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518 -#/ DELI!ER"5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555)! -# SUPPORT555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555)1 6#0

3LOSSA 3LO SSAR" R"####### ############## ############## ############# ############# ############## ############## ############# ############# ############## ################## ################################# #######################22 #22

4#0

REFERE REFERENCE NCES#### S########### ############## ############# ############# ############## ############# ############# ############## ############## #################### ################################2/ ###################2/

5#0

APPRO! APPRO!A AL############ L################### ############# ############# ############## ############## ############# ############# ############## ############## ############# ############# ############## ################ ##########2 #2

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Proe7$ No#8 Insert t.e ni9e -roect nmer associated 0it. t.is -articlar US5 Do7*me)$ No#8 Insert t.e Docment Identification $mer and e/ision5 Do7*me)$ De(7r'%$'o)8 Insert descri-tion of docment; e5g5 PU& S%&A( <&$&A%#; "&%% &=am-le User e9irements S-ecification5

#0INTRODUCTION Note: Insert your own description and introduction. You may wish to include your own requirements and specifics to allow the inexperienced reader, contractors, and suppliers adequate explanation to understand the scope of the equipment. Descrie 0.o -rodced t.e docment; nder 0.at at.ority; and for 0.at -r-ose5 Descrie t.e contractal stats of t.e docment5 Inclde or reference as an attac.ment t.e >legal? -aragra-. t.at commnicates -rc.asing terms and conditions in t.is section5 Descrie t.e relations.i- of t.is docment to ot.er docments5 %.is is im-ortant for e9i-ment t.at is -art of an integrated -rocess or line and 0ill .el- t.e S--lier to nderstand and as2 9estions t.at may ot.er0ise e o/erloo2ed5 efer to t.e &9i-ment Validation Plan t.at otlines t.e S--lier@s res-onsiilities is attac.ed5 emo/e any o-tions t.at are not a--licale for t.is -roect; if ot.er ses 0ill a--ly list eac. se-arately5 %.is is to e tilied as a gide for t.e ser to ans0er t.e maority of 9estions in/ol/ed in s-ecifying t.e >0.at? for t.e e9i-ment5 Addendms may e sed to rond ot t.e re9irements5

2#0O!ER!IE. The Barrier Isolator and HVAC System provides a mechanical separation between the controlled room environment, and the interior environment in which the pharmaceutical product is processed. The barrier isolator is manufactured in such a manner that the materials are resistant to corrosion, do not allow poolin of the cleanin materials, and allow access to the interior as

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re!uired by the e!uipment and products. The environment inside the barrier isolator is controlled in a manner to allow the pharmaceutical product to be processed in accordance with the purpose and product re!uirements. ".#

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The e!uipment shall be used primarily for& • Continuous 'roduction • Batch 'roduction (ther •

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%)$I'*%+T CASSI-ICATI(+

-or eample& -or providin an aseptic environment for& • i!uid fillin of vials with stoppers • 'owder fillin of vials with stoppers • i!uid fillin of ampoules with flame/off • i!uid fillin of cartrides with plus • i!uid fillin of syrines • (ther 0define1 Insert your Equipment Classifications here as required using the above example as a guide.

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C%A+I+3 4%)$I4%*%+TS • • • •

5ipedown *anual 5ashdown Clean/In/'lace 0CI'1 Special 4e!uirements& 6 'eracetic Acid 6 %thylene (ide 6 Chlorine 7ioide 6 Vapori8ed Hydroen 'eroide 6 (thers

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A+3$A3% 4%)$I4%*%+TS • • •

%nlish (ther 0Specify1& :::::::::::::::::::: Bilinual;
/#0OPERATIONAL REQUIREMENTS 351

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3.1.1 Capacity Add capacities and details concerning equipment capacity here. Identify the type and dimensions of the equipment that will fit inside of the barrier.

2."

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The Barrier Isolator and HVAC System is divided into two main portions& The barrier isolator, and the HVAC system. Barrier Isolator Operation The barrier isolator is an enclosure that provides isolation between the operator=outside environment and the interior of the barrier where the pharmaceutical processin is done. The barrier isolator provides the followin functions& 35)51

• • • • • • • •

Isolation between the operator and the process Safety Barrier to separate the operator from e!uipment ha8ards A non/corrosive, drainable, and easily cleaned enclosure. 7oors to provide access to the e!uipment durin cleanin and chaneover 3loveports to allow access to machinery and product durin production Transfer ports to introduce commodities and e!uipment to the environment Infeed openin to introduce commodities to the system. %it openin to allow finished commodities to eit the system.

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35)5)

Barrier Isolator Design

The barrier isolator desin will meet current 3*' for aseptic product manufacture, alon with wash down and saniti8ation re!uirements. #. All interior corners will have a minimum of :: >.?@ : radius. ".

7rain pans will have a minimum of :: >.?@ :: slope per #"@ of run.

2.

Hori8ontal surfaces will be minimi8ed to resist poolin. 'oolin of more than :: ?ml :: of li!uid is not allowed. 'ooled li!uid must not be more than :: "mm :: deep

9.

7rain pans shall terminate in tan bottom drain valves with materials and finish e!uivalent to the rest of the barrier isolator interior.

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Air distribution from the plenum will use :: dual perforated plates ::.

.

The air distribution system will be removable for cleanin.

2.".".# Safety of the operator from the machinery or processes within the barrier isolator must be ensured. . All doors will have dual/redundant safety switches that will immediately stop all machinery or processes when the door is opened. D.

3loveports will be uarded with liht curtains to immediately stop machinery.

E.

All movin machinery eternal to the barrier isolator will be fully uarded and alarmed.

#>. All hih temperature components eternal to the barrier isolator will be fully uarded and alarmed. 2."."." *aterials and -inish of the Barrier Isolator will meet current 3*'Fs. #. 5all thicness of the barrier isolator will be a minimum of :: aue : Stainless Steel ".

Interior surfaces of the barrier isolator will be manufactured from :: 2# :::::::: Stainless Steel.

2.

%terior surfaces of the barrier isolator and ductwor will be manufactured from :: 2>9 or2# ::: Stainless Steel.

9.

Interior finish of the barrier isolator will be of ::::::: 9> : micro/ inch 4a finish maimum.

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%terior finish of the barrier isolator will be of :::::: #"> : micro/ inch 4a finish maimum.

.

All interior surfaces will be electro/polished redundant; How else do you et G9 and G?;.

.

All welds will be round and polished to the above finish re!uirements.

D.

Air plenums must meet the same materials and finish re!uirements as the barrier isolator.

E.

The completed interior of the barrier isolator will be passivated prior to shipment to the site.

#>. Components attached to the eterior of the barrier isolator must meet current 3*'Fs and be finished to resist corrosion. 2.".".2 7oors and 5indows in the barrier isolator allow visibility and access to the interior. #. The window material is manufactured from :: tempered safety lass or polycarbonate ::. ".

The window sealin material is etruded from :: silicone rubber ::.

2.

5indow seals must be desined to prevent poolin.

9.

7oors must hine open to allow access to the interior.

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7oors must be removable without tools.

2.".".9 *ousehole (penin0s1 are provided at the eit point to allow the eit of ood vials and of reect vials. #. *ousehole covers are manufactured to the same re!uirements as the barrier Isolator. ".

*ousehole cover presence is to be sensed and alarmed.

2.".".? 3loveports are provided in the barrier isolator to allow operator access to the interior without compromisin sterility. #. 3loves must be replaceable. ".

3loves must be saniti8ed without absorbin sterilant.

2.

3loves will be made from :: fabric reinforced 'VC ::.

9.

3loves will be located to access common intervention points.

?.

3loves will be positioned to allow access by operators within the normal rane of physical si8es.

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2.".". Transfer 'orts will be provided to allow component and product entry into the interior of the barrier isolator without compromisin sterility. #. Transfer ports will be located at the followin locations, and are of the followin si8es& ocation G#& ::: upstream of filler :: :: 2?>mm :: ocation G"& ::: at stopper entry :::: :: ">mm :: ocation G2& ::: at outfeed :::::::: :: ">mm :: ocation G9& ::: +=A :::::::::::: :::::::::: ".

Transfer port manufacture is :::::::::::::::::::::

2.

Transfer port saniti8ation process is :::::::::::::::

2.".". Commodity='roduct Infeed to the interior of the barrier isolator will be provided in the desin. ##. Vials enter the barrier isolator from a :: depyroenation tunnel ::. #". 'roduct enters the barrier isolator throuh a :: bulhead fittin ::. #2. Stoppers enter the barrier isolator throuh :: transfer port G" ::::. #9. *iscellaneous 7evices such as&:: tools, S*A stands, haners, platforms, instrumentation, test ports, etc. ::: 2.".".D 'roduct %it from the interior of the barrier isolator will be provided in the desin. #?. Vial path G# transfers vials to a ::flat belt conveyor::. #. Vial path G" transfers vials to a ::""@ transfer dis::. #. 7rains in the bottom of the barrier isolator are provided at :::: points to allow for li!uids to be removed durin chaneover and saniti8ation. #D. 7rains must be closed durin production. 35)53

HVAC System Operation

The HVAC system controls the environment inside the isolator, and provides the followin functions& • • •

'ressure differential between the interior and eterior of the isolator Temperature control of the interior Humidity Control of the interior

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Doc ID: Barrier Isolator_US_!


November 26, 2002 • • •

Air Circulation throuh the interior H%'A=$'A filtration of the interior air Sanitation of the barrier isolator and the e!uipment This seems incorrect, it may maintain sanitation but not induce it.

35)5351 'ressure 7ifferential between the interior and eterior is maintained at positive >.#>@H "(, =/ >.>"@H "(. 'ressure balance is to be maintained within these parameters under all conditions of&

#E. 'roduct infeed doors open or closed ">. 'roduct enterin or not enterin "#. %it door open or closed "". 'roduct eitin or not eitin "2. *ultiple withdrawals of love ports "9. Transition of transfer ports "?. -luctuation of outside environment within tolerance

35)535) Temperature Control is maintained at =/ #.> °C of setpoint within the full temperature control rane of ?.> °C minimum to ?>°C maimum. Temperature control is to be maintained within these parameters under all conditions of&

#.

Beinnin of the batch

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on term continuous run of the batch

2.

-luctuation of outside environment within tolerance

35)5353 Humidity Control durin production is maintained at =/ #.> °C dew point within the full humidity rane of ?.> °C minimum to "?°C maimum. The system is desined to only lower the dew point. There are no provisions to raise the dew point above that of the ambient environment. Humidity control is to be maintained within these parameters under all conditions.

9.

7ryin of the barrier isolator after cleanin

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.

on term continuous run of the batch

.

-luctuation of outside environment with tolerance

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Doc ID: Barrier Isolator_US_!


November 26, 2002

35)5354 Air Circulation is provided by a variable speed fan circulatin the air throuh heatin, coolin, dehumidification, and filter systems. The air is forced into the barrier isolator throuh a perforated plate to disperse the air throuhout the interior uniformly. Air is then returned from the interior throuh the return air ducts. Airflow is measured #" inches below the perforated plates, and must be between ?> feet per second minimum to E> feet per second maimum. Air circulation levels are to be maintained within these levels under all conditions.

D.

Saniti8in cycle of the barrier isolator

E.


#>. on term continuous run of the batch ##. -luctuation of outside environment with tolerance 35)535, H%'A=$'A filtration of the recirculated air is provided by two pairs of filters in series. The filters are EE.EEJ efficient at removin particles reater than >.2 microns in si8e. The fresh air inlet uses a rouhin filter and a E>J efficient ASH4A% filter prior to the H%'A=$'A filters. 4ecirculated air filtration at all times that the HVAC fan is operatin 0frament1.

2.".2. Saniti8ation of the Barrier is provided by the followin processes& #". The interior of the barrier isolator is manually=automatically cleaned out of any debris from the previous production. All areas of the interior that can accumulate debris must be accessible to allow for removal of debris. #2. The interior surfaces of the barrier isolator are able to be wiped down by cleanin personnel easily and efficiently without daner to the personnel or damae to the materials. #9. The interior of the barrier isolator can be washed down with cleanin aents and water without poolin or deterioration of the interior surfaces. #?. The interior surfaces of the barrier isolator are drainable without ecessive poolin to allow rapid dryin of the interior. #. Cleanin aents are introduced by inection into the HVAC system throuh a port in the ductwor after the filters. #. The interior surfaces of the barrier isolator can be saniti8ed by ::::::::::::::: cleanin aents without damae to the surfaces of the barrier isolator.

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Barrier Isolat or URS Urs

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