BUSINESS MODEL · OEM

Your Process, Our Production Infrastructure

Toll
Manufacturing

Toll Manufacturing

Under this contract manufacturing model, SPCI replicates the customer’s established
standard operating procedures (SOPs) without modification at its commercial-scale production facilities.

  • SOP replication
  • Equipment operation
  • Certificate of analysis

When OEM Is Suitable

01

When the Process Is Already Established

Suitable for customers that have established commercial production conditions and require access to production equipment. SPCI performs the agreed scope of manufacturing without requiring separate development or process validation.

Toll processing

02

When Production-Scale Equipment Is Required

Suitable for customers with established SOPs but without access to production-scale reactors. SPCI selects an appropriate production line based on the characteristics of each process.

300–10,000 L, 26 reactors, total capacity: 76,450 L

03

Initial Production Runs

Suitable for customers that wish to begin with small-scale production at the start of a business relationship.

Initial production runs

04

When Specialized Equipment Is Required

Suitable for processes that require SPCI’s specialized equipment.

SPCI’s specialized equipment

Process Overview

The toll-manufacturing process consists of four stages, from receipt of the customer’s SOPs to submission of the certificate of analysis.

Stage
Description
Customer’s Role
Deliverables
  1. 01
    Receipt of SOPs
    Reviews the submitted SOPs, process conditions, and acceptance criteria
    Provides product specifications and process conditions
    Preliminary review
  2. 02
    Equipment Review
    Determines the reactor line and raw material supply method suited to the reaction conditions
    Confirms raw materials and supply method
    Equipment availability and schedule
  3. 03
    Production by Process Replication
    Manufactures the product according to the specified procedures without deviation
    —
    Production records
  4. 04
    Testing and Shipment
    Performs analysis within the agreed scope and ships the products together with the certificates of analysis
    Provides final acceptance
    Product and certificate of analysis

Mass Production Equipment for Customer Processes

Your Process,
Reliably Executed in SPCI’s Reactors

We select a suitable reactor line from among the reactor lines at our three plants,
ranging from 300 L to 10,000 L, according to the process conditions.
Our facilities support anhydrous and inert-atmosphere processes and processes involving hazardous materials.

  • 26 reactors; total capacity: 76,450 L; maximum capacity: 10,000 L
  • Operating temperature range: −30 to 250°C; high-pressure reactors available
  • Facilities authorized to handle Class 3, 4, and 5 hazardous materials; workplace subject to PSM requirements
  • Equipment Details – Infrastructure → Production Facilities
Reactor equipment at an SPCI production site

Roles and Responsibilities

In OEM manufacturing, clearly defining each party’s responsibilities from the outset benefits both parties.
SPCI specifies these roles and responsibilities at the contracting stage before proceeding with the project.

What the Customer Defines

  • Product specifications
  • Process conditions
  • Acceptance criteria
  • Raw materials and order of operations

What SPCI Provides

  • Production in accordance with the specified SOPs without deviation
  • Analysis within the agreed scope and submission of certificate of analysis
  • Handling of Class 3, 4, and 5 hazardous materials and support for anhydrous processes
  • Operation of 26 reactors with a total capacity of 76,450 L

As a general rule, we receive the SOPs before commencing a toll-manufacturing project. If product specification assurance is also required, we recommend an ODM engagement beginning at the development stage.

Inquiry Process

Provide your process conditions, and SPCI will review
equipment availability.

After receiving your inquiry, we assign a dedicated representative to provide one-on-one assistance.

Because OEM manufacturing involves reproducing the customer’s established process conditions,
the review can begin only after the reaction conditions and raw material supply method have been confirmed.

Information to include in your inquiry and information SPCI will provide
Information to Include in Your Inquiry Information SPCI Will Provide
Process conditions (reaction, temperature, and pressure) Equipment availability
Required quantity and delivery date Available production schedule
Raw materials and supply method Raw material verification and guidance on toll manufacturing terms
Confidentiality requirements Guidance on confidentiality procedures

Considering Toll Manufacturing for an Existing Process?

Tell us about your reaction conditions, raw material supply method, and required quantity, and we will advise you on equipment availability and a preliminary schedule.

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