Pharmaceutical Operations

Machine being Operated

Pharmaceutical operations which emit air contaminants require a permit to operate. The following information will assist in the completion and submittal of an application for each pharmaceutical operation. Each section of the page contains important information needed to process an application. 

Application Forms

The District collects information about equipment and processes that are required to have a permit by asking for completion of application forms. These forms tell us about your operation and allow us to permit your process. It is very important that these forms are filled out completely and accurately. Errors and missing information may lead to delayed processing time and  additional charges if revisions are required. Please carefully review and complete the forms. You may contact the District with any questions.

General Application Word PDF

Please provide a detailed description of the process and safety data sheets for all materials used in the operation. Please provide a process flow diagram (PFD) and a site map detailing the emissions points for this operation. 

Control Device (if applicable) Word PDF

Toxics Form Word PDF

The general application and toxic form with the PFD, safety data sheets, and site map must be submitted with each application packet. 

Best Available Control Technology

If a piece of equipment or a process emits more than 10 pounds per day of particulate matter (PM10), oxides of nitrogen (NOx), volatile organic compounds (VOC) or oxides of sulfur (SOx), the application must include a best available control technology (BACT) analysis. The District has a BACT guide to assist with the analysis. If you have questions or need assistance reference the contact information at the bottom of this page.

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Trade Secret

District rules address how information that is submitted to the District is managed. District Regulation IX contains District rules 176 and 177. Please refer directly to these rules when submitting trade secret information. However, be aware that you will need to submit:

1.       A letter disclosing the proprietary information. This can be submitted electronically.

2.       A letter for the public record explaining why the information needs to be held as trade secret.

The inclusion of proprietary information can significantly delay permit applications. In an effort to expedite the permit application process it is recommended that you contact the manufacturer or vendor of any proprietary materials that are used in the process and prepare the required letters as part of your application submittal. 

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Fees

The correct fee must be submitted with your application in order for it to be accepted. For this type of equipment, fees are determined based on the time and materials required to conduct the review, so a fee estimate must be obtained from the District prior to submittal. Please note that application fees are estimated and the final fee may be more or less than this amount based on time and materials spent processing the application. The District maintains work records for this purpose.

Before submitting an application, contact the District (see bottom of page) to obtain an application fee estimate for application submittal. Please note that an additional fee may also apply depending on the method of payment. A breakdown of how the application fee(s) are determined can be seen here. Additional information can be found in District Rule 40.

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How to Pay

These fees may be paid by check payable to "Air Pollution Control District" or by credit card (Visa, MasterCard, Discover, and American Express). 

If you choose to email or fax your application and intend on paying with a credit card, you must provide contact information (name and phone number) so that the District can complete payment.

Please note that credit card payments are assessed a transaction fee of 2.2% that is charged by the credit card provider.

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Application Status

The District is required to act on complete applications within 180 days. Typically permits are issued in about 60 days. More complex processes will take longer. Ensuring your application is complete is the best way to reduce processing time. Complete emissions data is the most important factor in minimizing application processing time and iterative information requests. If you have any questions about what information is required, please contact the District using the information at the bottom of this page. Learn more about the rules that govern application processing time. 

Sign up for Citizen Access to get up to date information on the status of your application.

Learn more about the application process and what to expect. 

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How to Submit Application Packet

Mail

SDAPCD

Permit Processing

10124 Old Grove Rd

San Diego, CA 92131-1649

Fax

(858) 586-2601

Select equipment type applications can now be submitted online through Citizen Access. Sign up today to get connected to your applications and permits. 

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NESHAP/NSPS/ATCM

Some pharmaceutical operations may be subject to NESHAP. The engineer assigned to your project will review the operation(s) in order to determine if any of these regulations apply.

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District Rules

Several District rules may apply to your equipment. The equipment specific rule that applies to pharmaceutical operations is Rule 67.15. A complete listing of the District's rules can be found here.

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Obtain Assistance

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Need Help? Have Questions?

Email the District or call (858) 586-2600 and ask for the duty chemical engineer.

More in depth help and site visits can be performed by the District Small Business Assistance Program Coordinator who can be reached at (858) 586-2656.