Sample Operations Narrative 01-Oct-03

PHE 535 / Lecture 5 / Architectural Design Guidelines / Operations Narrative

Sample Operations Narrative 01-Oct-03.doc 1

Concept of Operations

PERSONNEL

All employees entering the facility will use the Main Entrance.

Administrative staff who will not be entering the manufacturing areas can

proceed directly to their work places in street clothes. The remainder of the

personnel will use the following gowning procedures:

All personnel entering the manufacturing operations must change from street clothes into plant supplied and laundered uniforms.

Lockers will be supplied for each employee. The uniforms must be

left in the facility when departing. Once an employee has a put on a

uniform they may not leave the facility wearing it. This level will be

considered Uniformed Personnel (UP).

Personnel entering Class 100k clean space must add Hair & Shoe covers in the passthrough airlocks before entering the clean space.

This level will be Hair & Shoe Personnel (HSP).

Finally all personnel entering sterile and or virally contaminated space must be fully gowned. This should include full Tyvek or similar coverall (preferably with boots and hood attached), two layers

of latex or similar disposable gloves, micro-filtering mask, and full

goggles. No skin should be exposed to the room environment. This

will be fully gowned or Gowned Personnel (GP).



AIRLOCKS

There are a number of types Airlocks used in the facility. All are designed to

segregate one area from another for contamination control, for containment

or both. Each airlock or suite of airlocks will have electronic interlocks to

insure that only one door can be opened at a time. In case of a fire

emergency the door locks will be automatically overridden. The follow

describes in general the uses for this interstitial space.

Airlock (A/L) Throughout the facility these rooms separate two adjacent rooms with different air classifications. They are for

personnel or personnel carrying manually transportable items

such as samples for testing.

Equipment Lock (E/L) The equipment lock is used for the transfer of equipment and materials between two adjacent rooms

with different air classifications. Normal procedure is for a

Material Handler (MH) to deliver the material and place it in the

Equipment Lock. If possible the MH should do so without

physically entering the E/L. When the door is closed a MH or an

operator will retrieve the item from the other room, if possible

without entering the E/L. Hydraulic pallet jacks or carts are

particularly useful here.

Gown In Suite All personnel entering the Sterile Core will first enter an A/L then they will enter the Gown In suite. Within this

room they will put on the appropriate attire for the next level of



area classification. The final separation is the Step Over Bench.

Here personnel will don their final shoe cover and place the clean

booted foot on the opposite side of the bench.

Gown Out Suite All personnel leaving an area wherein viral components are handled will leave through a Gown Out or De-

Gown Suite. The objective is to assure that contaminants, which

may be on the exterior garments, are controlled. Personnel

leaving an operating area will follow a reverse procedure from

the one above, with the last step being removal of shoe covers as

they step over the bench.

HOUSEKEEPING

There are basically four levels of housekeeping in the facility. These are:

General all administrative, training, cafeteria and common corridors. General areas will be cleaned by janitorial personnel,

using normal household cleaners and equipment.

Clean Space areas which are maintained as Class 100k space. Primary concern for these areas is particulate contamination.

Clean space will require the personnel to vacuum and wipe-down

floors walls and ceilings.

Viral Space any area, which has the potential of being contaminated by live virus. The cleaning of Viral Space will

require the use of disinfectant cleaners to neutralize the active



virus. Rooms should be washed with a disinfectant cleaning

solution known to be effective on the particular viral strain. These

solutions will be changed regularly to avoid the virus becoming

resistant.

Sterile Space areas which are maintained to prevent contamination of sterile products and components. These will be

Class 10k and Class 100 space. Sterile Space will be cleaned as

outlined above in Viral Space. The intent is to remove any

contaminants, which can get into the product.

RECEIVING

Material Handlers (MH) (UP) in the receiving area will enter the receiving

area via the main corridor. Pallet loads of raw and packaging materials will

be delivered from the main warehouse in Building in daily quantities to

minimize staging requirements. The pallets will then be transferred into the

material airlock and picked up by a material handler on the clean side.

Materials going to the second level will be placed in the material lift.

All eggs will be received at a separate dock door. Pallet loads of boxed eggs

will be moved to the staging refrigerators using powered pallet jacks. Eggs

received on flats in racks will be moved manually. The egg racks can weigh

over 1,000 lb each and will require two handlers to move them. The eggs

will be placed in the staging refrigerators from one set of doors and will be

removed from the opposite end.



EGG WASH

Egg Preparation Operators (EPO) will be UP. They will enter the egg prep

area via the main corridor. EPOs will remove boxes of eggs with a

hydraulic pallet jack or racks of eggs manually from the staging refrigerator.

Boxed eggs must be manually unpacked on an inspection table and

transferred to plastic flats using a vacuum assisted egg lift. The device will

lift all 36 eggs from the pressboard flat and place them in a clean plastic flat.

Clean flats will be delivered to the area via an airlock to the clean corridor.

Eggs will be inspected for breakage and broken eggs will be replaced to

maintain full flats. The EPO will place the flat on the conveyor, which

passes through the wall to the egg washer. Corrugate and pressboard flats

will be compacted for disposal.

PRE-INCUBATION

The MHs in this area are HSP. They will take dried racks of eggs and

manually transfer them to the input side of the incubators. The racks are

pushed into the incubators manually, and there are tracks in the floor to

guide the casters. There are doors at both ends of the incubators to preserve

First In First Out (FIFO) control. The operators will pre-start the units before

starting to place the racks in, and temperature and humidity will be

controlled by a PLC.

PRE-INOCULATION CANDLING

At the end of the defined incubation period, the egg racks are manually

removed by a MH in HSP from the incubator and transferred into the Pre-

Inoculation Candling room via the 100k plant corridor. In the candling suite



the egg flats are manually removed from the rack by a MH in HSP using a

spoon and set on the staging section of a conveyor for transport. The

conveyor is constantly running with three sections separated by stops. The

Candlers in HSP are seated along both sides of the conveyor with candling

lights to inspect each egg for embryo viability, air sack location, and

cracking. Unsatisfactory eggs are manually discarded into a lined container.

INOCULATION

The conveyor from candling passes through a wall, which represents

another change in state. The Inoculation room is considered hot in that

live virus is handled here. This requires an additional level of gowning for

the Egg Handlers (EH). EH will be GP and will enter from the Class 100k

corridor through a gowning air lock, where they will put on additional

protection. Once the employee has entered the inoculation room they

cannot go back into the gowning suite and must exit through a prescribed

de-gowning area. The general area is Class 10k.

POST-INOCULATION INCUBATION

Incubators are provided to accommodate the post inoculation, incubation

step. MHs are GP in this area and must enter through a gowning suite and

depart through the de-gowning room. The MH will manually move racks

from the inoculation room to the input side of the incubators. The weight of

the egg-laden racks will require two operators. As with the pre-incubators,

these units will have tracks to guide the casters. The incubators are

equipped with doors at both ends to accommodate FIFO operations.



POST INOCULATION CANDLING

After the required incubation time has elapsed, the racks are manually

removed from the incubators, by a MH, in the order they were installed.

The racks are moved the post inoculation candling room and placed at the

upstream end of the candling conveyor. This room will be maintained as

Class 10k.

The conveyor is constantly running with three sections separated by stops.

Candlers (GP) are seated along both sides of the conveyor with candling

lights to inspect each egg for embryo viability, air sack location, and

cracking. Unsatisfactory eggs are manually discarded into a lined container.

HARVEST FEED

Chilled egg racks are manually removed from the chiller and transferred to

the Class 10k Harvest Feed Room by MH (GP). EH (GP) will manually

place the flats of chilled eggs on the infeed conveyor to the egg de-capper.

When a rack is emptied it will be placed into the automatic rack washer.

When the cycle is complete the cleaned and dried rack will be removed by a

MH (HSP) and stored in clean staging. The unit will pass through wall

separating the viral area from clean staging.

The flats of decapped eggs pass through a wall on the conveyor to the

Harvesting Room. The two conveyors will merge into one double stacked

unit under a Class 100 HEPA filtered Laminar flow hood. The decappped

flats will move to the Harvesters (GP) on the top conveyor. The fluid is

removed from the eggs by vacuum with a wand.



FIVE MICRON FILTRATION

FOs entering the Sterile Core will fully gown in the Gown In airlock. Once

inside the operation the FO cannot return to the gowning room. The FO

(GP) in the Five Micron Filtration room will manually connect a jacketed

vessel to the cooling system. They will take a bottle of thawed material and

using a parastaltic pump under a BSC transfer the contents to a holding

vessel.

CENTRIFUGATION

A Centrifuge Operator (CO) (GP) is responsible for the set up and startup of

the Centrifuge. COs entering the Sterile Core will fully gown in the Gown

In airlock. Once inside the operation the CO cannot return to the gowning

room.

The material will be manually transported to the Centrifuge room. The CO

will start the Centrifuge and add the gradient. A transport vessel with

filtered harvest fluid will be delivered to the Centrifuge Room from the

Filtration manually. The jacketed vessel will be connected to the cooling

system and the harvest fluid feed lines will be connected to the transfer

pump using a LAF hood. When the centrifugation is complete the CO will

collect the fractions in separate bottles using the LAF to insure no

contamination. The CO will manually transfer the dirty transfer vessel and

contaminated tubing to the dirty corridor equipment lock.



POOLING AND STERILIZING OF FRACTIONS

The CO will manually deliver the selected, pooled fractions to the Sterilizing

Operator (SO) (GP). As with the previous sterile suites doors will be

interlocked. The SO will have entered the sterile core through the gowning

suite. The SO will pump the vials into a mixing vessel under a BSC to

reduce the chance of contamination. Under a Class 100 LAF the SO will

pump the pooled fractions through the sterilizing filter into bulk bottles.

EQUIPMENT WASHING

Equipment Washers (EW) (HSP) will remove decontaminated equipment

from the pass through Autoclaves and place it in the staging area. Large

equipment items such as tanks and large waste containers are manually

moves on casters to the Tank Washer. Glassware and small containers are

manually removed from the decon carts and placed on the infeed conveyor

to the Glassware/Parts Washer. Additional small machine components

such as inoculator heads and decapper tooling are manually placed in the

Ultrasonic Sinks for cleaning.

Sample Operations Narrative 01-Oct-03

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