ProFiller 3800 User manual

Operating Instructions
OVERVIEW
Read the Before You Begin section on page 11 of the ProFiller 3700/3800 Manual v 1.2.1 before using this machine.
A. ORIENTATION OF OUTER CAPSULES
Orient the capsules as shown in the ProFiller 3700/3800 Manual v 1.2.1 Operating Instructions for Orientation, page 12 steps 1-9 using the Orienter and
Caps Tray for the outer capsule size.
B. SEPARATION OF CAPSULE CAPS AND BODIES
1. Make sure Cam Handle is at 0° on cam
indicator. Place loaded Caps Tray with Push
Plate onto Filler.
2. Pull Cam Handle towards you until you feel
a noticeable resistance, securing capsule
bodies in Filler.
3. To separate size AAel capsules, see Inset
1 on next page. For other capsule sizes,
slowly push down Lifting Handle just until
capsules separate. As soon as you begin to
feel resistance, slowly release the Lifting
Handle. This resistance occurs as the
Bottom Plate begins to lift the capsule bodies.
Continuing past this point will cause the
capsule bodies to be lifted out of the Filler.
See Capsule Separation Tip below.
Capsule Separation Tip
If more than 1 or 2 caps fail to separate from bodies in step 3 when filling sizes AAA AA, AAel or A, or if more than 8 to 10 fail to separate for sizes B or D, Cam Handle
should be rotated to a higher degree on Cam indicator in step B2. When rotating Cam Handle, there should be enough pressure on capsule bodies to hold them inside
Filler, but not so much that capsules are squeezed to an oval shape.

Operating Instructions
INSET 1 (for Step 3): SEPARATING SIZE AAel Capsules
a. The Body Ejector Stopper
stops motion of the Lifting Handle
after size AAel capsule
separation to prevent ejection of
capsule bodies from the Filler.
b. Before Separation (Step 3),
align front of Body Ejector
Stopper with back of Base Frame
as shown in the photo.
c. In Step 3, press the Lifting
Handle until it touches the Body
Ejector Stopper, then release it
slowly. After separation, remove
the Stopper Block before locking
the capsules.
4. Lift Caps Tray with the Push Plate slowly.5. Set Caps Tray with Push Plate on table.
Slide Push Plate off Caps Tray to avoid lifting
caps due to static.
6. Place Caps Tray on Unseparated Capsule
Ejector Plate (a).
a

Operating Instructions
7. Capsules that have not separated will be
pushed higher up in Caps Tray. Remove
these capsules and separate the cap from
the body by hand. Insert the cap back in the
Caps Tray and insert the body into the Filler.
8. Push Cam Handle away from you to return
Cam Indicator to 0º. This allows bodies to
drop.
9. Use smaller OE Push Plate to seat bodies
in Filler. See Capsule seating Tips below.
Capsule SeatingTips
After using the Push Plate, all capsule bodies may not sit at an even level in Filler. This is because of variation in capsule body shape (round to slightly oval), diameter
(capsule bodies vary by 0.12 mm within the same batch for most manufacturers), length of capsule body (can vary up to 1 mm within the same batch), type of capsule
(gelatin, hpmc, other) and manufacturer. After the first tamp or vibration cycle, the capsule bodies will be pushed down to the Bottom Plate. The top of the bodies still
may not all be level due to capsule body length variation. There is no effect on fill weight variation due to the initial height of the capsule body in the Filler.
We recommend that the top of the capsule bodies sit 0.5 – 1 mm below the top of the Filler. Positioning bodies exactly even with top of Filler will lower the average fill
weight, and could result in some bodies sticking out above the Body Sheets due to capsule length variation. To adjust capsule body height, see page 14 Adjust Bottom
Plate Height.

Appendix 1
Over-Encapsulating Tablets into Capsules
INSERTING TABLETS INTO OUTER CAPSULES
The number of holes will differ by size. This does not affect the instructions for use except where noted.
Capsule
Size Number of Outer Capsules in Filler Number of Holes in Attachment Number of Cycles
A, B, D 270 90 3
AA, AAel 180 180 1
AAA 120 120 1
1. These instructions begin after outer
capsules are oriented, separated, and seated
into Filler. 2. Place the OE Guide Tray on the Filler. 3. Pour tablets onto ATF and tilt in all directions moving capsules into slots.

Appendix 1
Over-Encapsulating Tablets into Capsules
4. Tilt the ATF to pour off excess tablets. 5. Place ATF locating studs into front holes
of OE Guide Tray. 6. Press release bar to drop the tablets into the capsules.
7. For sizes A, B and D only, remove ATF
and repeat steps 3-6 except in step 5 place
the ATF locating studs into the second holes
of OE Guide Tray. Repeat steps 3-6 a third
time, placing ATF studs into third holes in
step 5.
8. For all sizes, remove ATF and OE Guide
Tray. Verify that tablets are inside all
capsule bodies.
Tip: To avoid tablet rattling, fill capsules with
excipient.
9. Continue with “Operating Instructions” in
your ProFiller 3700/3800 Manual. Begin with
“Filling Capsules” if adding an excipient (page
18 in Manual v 1.2.1), or continue with
“Locking Capsules” to lock the outer capsules
(page 20 in v 1.2.1).

Appendix 2
Over-Encapsulating Caplets into Capsules
PARTS IDENTIFICATION - CAPLET-IN-CAPSULE ATTACHMENT (ORDERED SEPARATELY)
Filling caplets inside capsules can be done
using the custom-made Caplet Fill Attachment
(ACF). The outer capsules are oriented and
separated as usual. The caplets are inserted
into the open capsules, then the outer capsules
are locked. To avoid rattling, the outer capsule
can be filled with excipient before locking.
Batch Sizes
The number of holes will differ by size. This does not affect
the instructions for use except where noted.
Capsule
Size
Number of
Outer
Capsules in
Filler
Number of
Holes in
Attachment
Number of
Cycles
A, B, D 270 90 3
AA, AAel 180 90 2
AAA 120 60 2
INSERTING CAPLETS INTO OUTER CAPSULES
1. These instructions begin after outer capsules
are oriented, separated, and seated into Filler. 2. Place the OE Guide Tray onto the Filler. Steps for caplet orientation are similar to
capsule orientation.
3. Place the Caplet Orienter Base on the OE
Guide Tray. Align the front edge of the Caplet
Orienter Base with horizontal line I on OE
Guide Tray. Align the right edge of the Caplet
Orienter Base with the right edge of the OE
Guide Tray.
OE Guide
Tray
Caplet Tray
Caplet
Orienter Base

Appendix 3
Over-Encapsulating Capsules into Capsules
28
PARTS IDENTIFICATION - CAPSULE-IN-CAPSULE ATTACHMENT (ORDERED SEPARATELY)
Filling capsules inside larger capsules can be
done using both the ProFiller 3700 (sizes 00-5
only) and the ProFiller 3700OE (sizes AAA-D).
The outer capsules are oriented and separated
as usual. To over-encapsulate the smaller
capsules inside the outer capsules, the steps
are the same as for outer capsule orientation
except the Caps Tray is replaced with the OE
Guide Tray. The number of holes must be the
same during the orientation process for both the
outer and inner capsules.
Batch Sizes
The number of holes will differ by size. This does not affect
the instructions for use except where noted.
Capsule
Size
Number of
Outer
Capsules in
Filler
Number of
Holes in
Attachment
Number of
Cycles
A, B, D 270 90 3
AA, AAel 180 90 2
AAA 120 60 2
INSERTING CAPSULES INTO OUTER CAPSULES
1. These instructions begin after outer
capsules are oriented, separated, and seated
into Filler.
2. Place the OE Guide Tray onto the Filler
Base. 3. Place the Capsule Orienter Base on the OE Guide Tray. Align the front edge of the
Orienter Base with horizontal line I on OE
Guide Tray. Align the right edge of the
Orienter Base with the right edge of the OE
Guide Tray.
Orienter
Base
Orienter
Tray OE Guide
Tray

Appendix 2
Over-Encapsulating Caplets into Capsules
4. Pour caplets onto Caplet Tray and tilt in all
directions moving caplets into slots. 5. Tilt Caplet Tray to pour off excess caplets. 6. Place Caplet Tray on Caplet Orienter Base and slide back until it drops into place.
7. Push sliding portion of Caplet Tray to the left
to drop the caplets into the capsules. 8. For all sizes, move the Caplet Orienter Base with Caplet Tray to position II on OE Guide Tray.
Repeat steps 4-7.
For sizes A, B, and D only, a third cycle is
required. Move the Caplet Orienter Base with
Caplet Tray to position III on OE Guide Tray.
Repeat steps 4-7.
9. Remove the Caplet Orienter Base, Caplet Tray
and OE Guide Tray. Continue with Operating
Instructions in your ProFiller 3700/3800 Manual.
Begin with “Filling Capsules” if adding an
excipient (page 18 in Manual v 1.2.1), or
continue with “Locking Capsules” to lock the
outer capsules (page 20 in v 1.2.1).

Operating Instructions
D. LOCKING CAPSULES
After inserting trial product or filling powder, follow the instructions in the ProFiller 3700/3800
Manual Operating Instructions for “Locking Capsules” (page 20 in Manual v 1.2.1).